US9011414B2 - Systems and methods for hernia repair - Google Patents
- ️Tue Apr 21 2015
US9011414B2 - Systems and methods for hernia repair - Google Patents
Systems and methods for hernia repair Download PDFInfo
-
Publication number
- US9011414B2 US9011414B2 US14/140,652 US201314140652A US9011414B2 US 9011414 B2 US9011414 B2 US 9011414B2 US 201314140652 A US201314140652 A US 201314140652A US 9011414 B2 US9011414 B2 US 9011414B2 Authority
- US
- United States Prior art keywords
- elongated member
- arm members
- distal
- members
- arm Prior art date
- 2009-04-04 Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Fee Related
Links
- 230000008439 repair process Effects 0.000 title claims abstract description 68
- 206010019909 Hernia Diseases 0.000 title claims description 84
- 238000000034 method Methods 0.000 title claims description 33
- 230000008878 coupling Effects 0.000 claims description 38
- 238000010168 coupling process Methods 0.000 claims description 38
- 238000005859 coupling reaction Methods 0.000 claims description 38
- 239000013013 elastic material Substances 0.000 claims description 2
- 238000006073 displacement reaction Methods 0.000 claims 2
- 208000035091 Ventral Hernia Diseases 0.000 abstract description 16
- 206010060954 Abdominal Hernia Diseases 0.000 abstract description 15
- 239000007943 implant Substances 0.000 abstract description 10
- 210000003815 abdominal wall Anatomy 0.000 description 9
- 238000003780 insertion Methods 0.000 description 5
- 230000037431 insertion Effects 0.000 description 5
- 230000008901 benefit Effects 0.000 description 4
- 239000000463 material Substances 0.000 description 4
- 125000006850 spacer group Chemical group 0.000 description 4
- 230000006835 compression Effects 0.000 description 3
- 238000007906 compression Methods 0.000 description 3
- 230000007547 defect Effects 0.000 description 3
- 210000003813 thumb Anatomy 0.000 description 3
- 230000009977 dual effect Effects 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 230000008569 process Effects 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 230000000087 stabilizing effect Effects 0.000 description 2
- 208000029836 Inguinal Hernia Diseases 0.000 description 1
- 241000287107 Passer Species 0.000 description 1
- 208000005646 Pneumoperitoneum Diseases 0.000 description 1
- 208000002847 Surgical Wound Diseases 0.000 description 1
- 239000000853 adhesive Substances 0.000 description 1
- 230000001070 adhesive effect Effects 0.000 description 1
- 229910052782 aluminium Inorganic materials 0.000 description 1
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 1
- 230000015556 catabolic process Effects 0.000 description 1
- 239000002131 composite material Substances 0.000 description 1
- 230000006378 damage Effects 0.000 description 1
- 238000002224 dissection Methods 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 210000003195 fascia Anatomy 0.000 description 1
- 210000003811 finger Anatomy 0.000 description 1
- 239000004519 grease Substances 0.000 description 1
- 210000004013 groin Anatomy 0.000 description 1
- 238000002357 laparoscopic surgery Methods 0.000 description 1
- 230000007246 mechanism Effects 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 238000012978 minimally invasive surgical procedure Methods 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 230000036316 preload Effects 0.000 description 1
- 229910001220 stainless steel Inorganic materials 0.000 description 1
- 239000010935 stainless steel Substances 0.000 description 1
- 238000001356 surgical procedure Methods 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 238000003466 welding Methods 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/34—Trocars; Puncturing needles
- A61B17/3468—Trocars; Puncturing needles for implanting or removing devices, e.g. prostheses, implants, seeds, wires
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/0057—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect
- A61B2017/00575—Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect for closure at remote site, e.g. closing atrial septum defects
- A61B2017/00597—Implements comprising a membrane
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/0063—Implantable repair or support meshes, e.g. hernia meshes
- A61F2002/0072—Delivery tools therefor
Definitions
- the invention generally relates to minimally invasive hernia repair systems.
- the present invention relates to a minimally invasive implant-based ventral hernia repair system and method of operation.
- a hernia is a weakness in a particular anatomical surface which allows an internally contained organ to protrude.
- Ventral hernias are a type of hernia resulting primarily from weaknesses in the abdominal wall.
- Hernias of the groin region, or inguinal hernias are a separate type of abdominal wall hernia which are repaired with a different subset of surgical equipment and techniques. Repair of ventral hernia defects conventionally utilized open primary sutured repair. However, recurrence rates of ventral hernias after an open primary suture procedure were determined to be unacceptably high.
- Open mesh repair utilizes a synthetic or biologic mesh to correct the hernia but is still performed as an open invasive procedure.
- Open mesh repair has recently been replaced by laparoscopic, or minimally invasive, mesh repair. Recurrence rates have been shown to be lower after laparoscopic ventral hernia repair with respect to open repair.
- Laparoscopic type hernia repair reduces dissection and destruction of the structurally important fascial layers of the abdominal wall via the use of small incisions in the fascia, through which trocars are placed for instrumentation.
- small incisions can potentially develop into new hernias, especially in patients with a demonstrated propensity to developing fascial breakdown. Therefore, fewer trocars utilized to perform an operation generally results in a lower recurrence rate.
- Conventional laparoscopic surgical techniques for ventral hernia repair commonly require up to six trocars and corresponding incisions for proper manipulation of instruments and mesh implants.
- the invention generally relates to minimally invasive hernia repair systems.
- One embodiment of the present invention relates to a minimally invasive implant-based ventral hernia repair system.
- the system includes a first elongated member with an internal channel extending between a distal and proximal opening.
- a second elongated member extends through the internal channel of the first elongated member.
- a set of arm members is moveably coupled to the distal end of the first elongated member such that the arm members have a restricted freedom of movement with respect to the first elongated member.
- the arm members each include a set of lengthwise moveably intercoupled segments.
- a set of tension members extends lengthwise along the arm members and is rigidly coupled between the distal most segment of each arm member and the second elongated member.
- the degree of tension in the tension members corresponds to the configuration of the arm members with respect to the first elongated member.
- the proximal translation of the second elongated with respect to the first elongated member causes tension on the tension members, which thereby articulates the arm members into a radial extended configuration in which the arm members extend radially and substantially perpendicular to the first elongated member.
- a mesh is releasably coupled to the distal side of the arm members to facilitate coupling over the corresponding hernia.
- a second embodiment of the present invention relates to a method of distally coupling a mesh over a ventral hernia in the abdominal wall and subsequently removing the remainder of the hernia repair system.
- Embodiments of the present invention represent a significant advancement in the field of ventral hernia repair.
- Conventional minimally invasive ventral hernia repair systems and procedures utilize multiple instruments and openings in the abdominal wall to position and suture a mesh or implant over the hernia.
- Embodiments of the present invention provide a self-contained system for hernia mesh deployment and suturing through the hernia opening itself.
- the unique selectively restricted movement freedom of the arm members enables the system to be inserted through the internal channel of a trocar, coupled with a mesh over the distal opening of a hernia, and the remainder removed from between the mesh and hernia. This presents an advantage because the number of abdominal wall openings made in a hernia repair procedure has been determined to directly correspond to hernia recurrence rate.
- FIG. 1 illustrates a perspective view of a hernia repair system and corresponding trocar in accordance with one embodiment of the present invention
- FIG. 2 illustrates an exploded view of the hernia repair system illustrated in FIG. 1 ;
- FIG. 3 illustrates a detailed perspective view of the distal end of the first and second elongated members of the hernia repair system illustrated in FIG. 1 ;
- FIG. 4 illustrates a detailed perspective view of the arm members and the distal ends of the first and second elongated members of the hernia repair system illustrated in FIG. 1 ;
- FIGS. 5A-5F illustrate cross-sectional views of the hernia repair system of FIG. 1 along the corresponding axis A-A′ through F-F′;
- FIG. 6 illustrates a detailed perspective view of the distal segment of a single arm member of the hernia repair system illustrated in FIG. 1 ;
- FIG. 7 illustrates a profile view of the proximal ends of the first and second elongated member of the hernia repair system illustrated in FIG. 1 ;
- FIG. 8 illustrates a detailed perspective view of the mesh coupled to the distal side of the arm members of the hernia repair system illustrated in FIG. 1 ;
- FIGS. 9A-9B illustrate perspective views of the proximal ends of the first and second elongated member corresponding to two different operational states of the hernia repair system illustrated in FIG. 1 ;
- FIG. 10 illustrates a detailed perspective view of the distal ends of the first and second elongated members in an unlocked configuration of the hernia repair system illustrated in FIG. 1 ;
- FIG. 11 illustrates a detailed perspective view of the distal ends of the first and second elongated members in a locked configuration of the hernia repair system illustrated in FIG. 1 ;
- FIG. 12 illustrates a detailed perspective view of the arm members, mesh, and the distal ends of the first and second elongated members in a distal lengthwise extended, or undeployed configuration of the arm members of the hernia repair system illustrated in FIG. 1 ;
- FIG. 13 illustrates a detailed perspective view of the arm members, mesh, and the distal ends of the first and second elongated members in a radial extended configuration of the arm members of the hernia repair system illustrated in FIG. 1 ;
- FIG. 14 illustrates a detailed perspective view of the arm members and the distal ends of the first and second elongated members in a partially refracted configuration of the hernia repair system illustrated in FIG. 1 ;
- FIG. 15 illustrates a perspective view of an alternative hernia repair system incorporating multiple independent alternative configurations
- FIGS. 16-19 illustrate coupling acts of an independent mesh and suture to the alternative system illustrated in FIG. 15 ;
- FIG. 20 illustrates an optional guiding system disposed over the arm members and mesh
- FIGS. 21-22 illustrate optional confinement procedures for confining the arm members and mesh in accordance with embodiments of the present invention.
- the invention generally relates to minimally invasive hernia repair systems.
- One embodiment of the present invention relates to a minimally invasive implant-based ventral hernia repair system.
- the system includes a first elongated member with an internal channel extending between a distal and proximal opening.
- a second elongated member extends through the internal channel of the first elongated member.
- a set of arm members is moveably coupled to the distal end of the first elongated member such that the arm members have a restricted freedom of movement with respect to the first elongated member.
- the arm members each include a set of lengthwise moveably intercoupled segments.
- a set of tension members extends lengthwise along the arm members and is rigidly coupled between the distal most segment of each arm member and the second elongated member.
- the degree of tension in the tension members corresponds to the configuration of the arm members with respect to the first elongated member.
- the proximal translation of the second elongated with respect to the first elongated member causes tension on the tension members, which thereby articulates the arm members into a radial extended configuration in which the arm members extend radially and substantially perpendicular to the first elongated member.
- a mesh is releasably coupled to the distal side of the arm members to facilitate coupling over the corresponding hernia.
- a second embodiment of the present invention relates to a method of distally coupling a mesh over a ventral hernia in the abdominal wall and subsequently removing the remainder of the hernia repair system. Also, while embodiments are described in reference to ventral hernia repair, it will be appreciated that the teachings of the present invention are applicable to other areas. For example, embodiments and teachings of the present invention may be utilized to repair other types of hernias.
- Endoscopic surgery concisely defined to include all minimally invasive surgical procedures, including but not limited to laparoscopy, thoracoscopy and arthroscopy.
- Hernia a weakness or recess in a particular anatomical surface which allows an internally contained organ to protrude.
- the internal side of the herniated surface is referred to herein as the distal side.
- the external side of the herniated surface is referred to herein as the proximal side.
- a particular type of hernia referred to as a ventral hernia involves a weakness in the abdominal wall.
- Trocar a cylindrical device which may be inserted through a surgical incision to provide a channel through a body wall to the intended internal surgical region.
- Distal an anatomical surgical reference term used herein to refer to a region toward the body of the patient.
- a trocar disposed within a patient is oriented such that the distal end is disposed within the surgical field and/or the patient's body.
- Proximal an anatomical surgical reference term used herein to refer to a region away from the body of the patient.
- a trocar disposed within a patient is oriented such that the proximal end is disposed external to the patient's body.
- Mesh a general term used to describe any synthetic or biologic implant configured to extend over and cover the internal opening/weakness of a hernia.
- Needle a general term used to describe any suture device configured to couple a mesh over a hernia.
- Needle-suture pack any type of independently prepared package including a needle pre-coupled to a suture.
- Laparoscopic suture passer a type of transfacial suturing device that enables external suturing independent of the main system or trocar.
- Spring-biased clamp a clamping member including a releasable opening biased toward a closed position.
- FIG. 1 illustrates a perspective view of a hernia repair system and corresponding trocar, designated respectively at 100 and 200 .
- Minimally invasive hernia repair procedures initially include inserting a trocar through the herniated surface, thereby creating a proximal to distal channel through the hernia in the abdominal wall.
- the trocar provides an access channel through which instruments may be inserted distal to the hernia.
- Conventional laparoscopic hernia repair procedures require the insertion of additional trocars in the vicinity of the hernia to enable additional instruments to access the distal side of the herniated surface.
- Embodiments of the present invention include a system that is designed to operate exclusively through a single trocar 200 positioned through the hernia.
- the illustrated hernia repair system 100 is configured to be inserted through the internal channel of the trocar 200 onto the distal side of the hernia so as to expand and implant a repair mesh over the hernia.
- the illustrated trocar 200 is for reference purposes only, and it will be appreciated that the illustrated embodiment may be utilized with other trocars.
- the hernia repair system 100 includes a first elongated member 120 , a second elongated member 140 , a plurality of tension members 210 , and a plurality of arm members 180 .
- the illustrated first elongated member 120 is cylindrically shaped with a particular external diameter and curvature corresponding to the diameter of the internal channel of the illustrated trocar 200 . It will be appreciated that various diameters and shapes may be utilized in accordance with embodiments of the present invention.
- the external surface of the first elongated member 120 is configured to facilitate a smooth translation within the internal channel of the trocar 200 .
- the first elongated member 120 is illustrated with a distal end oriented towards the left and a proximal end oriented to the right.
- the plurality of arm members 180 are moveably coupled to the distal end of the first elongated member 120 .
- the plurality of arm members 180 are distally extended and capable of three dimensionally conforming to the diameter of the internal channel of the trocar 200 .
- the second elongated member 140 is lengthwise extended through the first elongated member 120 .
- the second elongated member 140 is illustrated with a distal end towards the left and a proximal end oriented to the right.
- the hernia repair system 100 generally includes a first elongated member 120 , a second elongated member 140 , a plurality of arm members 180 , and a plurality of tension members 210 .
- the first elongated member 120 includes a cylindrical region 124 , a proximal end 122 , an internal channel 125 , and a distal end 130 .
- the cylindrical region 124 is an elongated hollow member which may be composed of a rigid metal material such as stainless steel or aluminum. The cylindrical region 124 is positioned between the proximal and distal ends 122 , 130 of the first elongated member 120 .
- the internal channel 125 extends lengthwise within the cylindrical region 124 .
- the particular external shape, diameter, and surface texture of the cylindrical region 124 are configured to correspond to the diameter of the internal channel of a trocar.
- the proximal end 122 includes a dual recess handle shaped region to facilitate operation. It will be appreciated that various handle shapes may be utilized to accommodate different functionalities.
- the illustrated dual recess shape provides a surface upon which a user's fingers may oppose a distal or proximal oriented thumb force upon the second elongated member 140 with respect to the first elongated member 120 .
- the illustrated handle shaped region is coupled to the cylindrical region via a recess within which the cylindrical region 124 is extended.
- the handle region may be composed of a rigid plastic composite material.
- the internal channel 125 extends through the proximal end 122 and handle shaped region to a proximal opening on a proximally oriented surface of the proximal end 122 .
- the distal end 130 includes a coupler region 128 moveably coupled to the plurality of arm members 180 .
- the coupler region 128 includes a plurality of radially oriented recesses 126 , a plurality of radially oriented arm member articulation regions 132 , and a plurality of radially oriented spacer regions 134 .
- the internal channel 125 extends through the distal end 130 to a distal opening on a distal oriented surface.
- the plurality of arm members 180 are moveably coupled to the distal end 130 so as to facilitate a restricted freedom of movement radially oriented within the arm member articulation regions 132 .
- the spacer regions 134 radially space the articulation of the arm members 180 from one another.
- the illustrated shape of the distal end is substantially cylindrical to maintain total system conformity to within the diameter of the internal trocar channel in a particular distal extended configuration.
- a smaller diameter region is positioned between the cylindrical region 124 and the arm member articulation region 132 .
- the smaller diameter region provides a transition region for the tension members 210 to extend between the internal channel 125 and the arm members 180 without radially extending beyond the diameter corresponding to the internal channel of a trocar 200 .
- the recesses 126 are disposed in the smaller diameter region and extend between the exterior and the internal channel 125 .
- the arm members 180 are moveably coupled to the distal end 130 of the first elongated member 120 to limit the articulation of the arm members 180 between a lengthwise extended distal configuration ( FIG. 12 ) and a radial extended configuration ( FIG. 13 ).
- the particular coupling between the distal end 130 and the arm members 180 may utilize a pin type connection oriented across and through the arm member articulation regions 132 and the arm members 180 so as to facilitate a substantially lengthwise (proximal to distal) oriented articulation.
- the shape and positioning of the pin with respect to the arm members 180 and the arm member articulation regions 132 will restrict the lengthwise freedom of articulation of the arm members 180 to within 180 degrees.
- the arm members 180 further include a plurality of intercoupled segments including a proximal segment 182 , medial segments 184 , and a distal segment 190 . Configuration and specifications of the segments will be described in more detail with reference to subsequent figures.
- the intercoupled segments are moveably coupled to one another in a configuration that restricts relative lengthwise articulation to within 90 degrees between individual segments.
- the intercoupled segments may utilize a male region 188 , female region 187 , and a pin 186 extending perpendicular as illustrated and described further in reference to FIG. 6 .
- the restricted moveable couplings between the distal end 130 and the proximal segment 182 , and between the individual segments 182 , 184 , 190 operate to restrict the overall articulation freedom of the arm members 180 to between the lengthwise extended distal configuration ( FIG. 12 ) and the radial extended configuration ( FIG. 12 ).
- Various types of analogous restricted moveable coupling schemes may be utilized in accordance with embodiments of the present invention.
- a plurality of tension members 210 are rigidly coupled to and extending between the distal segment 190 of each of the arm members 180 and the second elongated member 140 .
- the tension members 210 may be any type of lengthwise substantially flexible member including but not limited to cables, sutures, threads, wires, etc.
- the tension members extend substantially lengthwise along the segments of the arm members 180 , through the recesses 126 in the distal end 130 of the first elongated member 120 to the internal channel of the first elongated member, and are coupled to the second elongated member 140 .
- the length and relative tension of the tension members 210 corresponds to the configuration of the plurality of arm members 180 with respect to the first elongated member 120 .
- the tension members 210 extend substantially along the distal oriented side of the segments of the arm members 180 if the arm members 180 are positioned in the radially extended configuration ( FIG. 12 ).
- the tension members 210 extend from the recesses 126 through a hole on a proximally oriented side of the proximal segment 182 in the smaller diameter region of the distal end 130 of the first elongated member 120 .
- the coupling and length of the tension members 210 with respect to the second elongated member 140 are configured such that there is no tension if the proximal end 144 of the second elongated member is adjacent to the proximal end 122 of the first elongated member 120 ( FIG. 7 ).
- the second elongated member 140 includes a proximal end 142 , a locking pin 144 , a flat region 146 , a notch 148 , an O-ring 141 , a medial region 150 , a washer 151 , a threaded region 152 , a nut 143 , a shaft 156 , and a distal end 160 .
- the majority of the second elongated member 140 is disposed within the internal channel 125 of the first elongated member 120 during operation, with the exception of the proximal and distal ends 142 , 160 .
- the proximal end 142 includes a single recess curved handle shaped region.
- the illustrated single recess shape provides a surface upon which a user's thumb may exert a distal or proximal oriented thumb force upon the second elongated member 140 with respect to the first elongated member 120 .
- the operational movement between the proximal ends 122 , 142 of the first and second elongated members 120 , 140 is in part analogous to the operation of a syringe.
- the proximal end 142 is operationally coupled over a corresponding cylindrical portion of the medial region 150 via the pin 144 .
- the flat region 146 and notch 148 are shaped to facilitate an operational locking of the second elongated member 140 in a particular proximally translated and rotated position with respect to the first elongated member 120 ( FIG. 9B ).
- the shape of the flat region 146 and notch 140 correspond to the shape of the proximal opening to the internal channel 125 on the proximal end 122 of the first elongated member 120 .
- the O-ring 141 is a rubber circular member circumscribing the medial region 150 to facilitate a smooth operational translation between the first and second elongated members 120 , 140 .
- the O-ring 141 may also be configured to include an airtight wax, rubber, or grease seal to form a seal therebetween that prevents leakage and release of the intra-abdominal insufflation gas required to maintain a pneumoperitoneum for operative working space.
- the medial region 150 is a partially cylindrical region externally shaped to correspond to the internal channel 125 of the first elongated member 120 .
- the rubber washer 151 and nut 143 provide a compression type coupling scheme between the tension members 210 and the second elongated member 140 . In an assembled configuration (not shown), the tension members 210 extend along grooves 154 in the threaded region 152 and are compression coupled to the medial region via the rubber washer 151 and the nut 143 .
- the shaft 156 includes a non-circular cross-sectional shape so as to facilitate rotational binding with the remainder of the second elongated member 140 .
- the illustrated shaft 156 is square shaped and disposed within a corresponding square recess within the threaded region 152 so as to enable rotational coordination between the proximal end 142 and the distal end 160 of the second elongated member 140 .
- the proximal end of the shaft 156 is releasably disposed and/or coupled within the square recess of the threaded region 152 .
- the distal end 160 is directly coupled to the shaft 156 via a welding or adhesive type coupling.
- the distal end 160 may also be referred to as a locking member in that it functions to selectively lock the articulation freedom of the proximal segment 182 of the arm members 180 .
- the distal end 160 of the second elongated member 140 includes the illustrated threaded male region that couples within a corresponding female threaded region on the distal end 130 of the first elongated member 120 .
- the corresponding coupling between the threaded regions obstructs translational freedom but enables rotational freedom between the distal ends 130 , 160 of the first and second elongated members 120 , 140 .
- the distal end 160 includes a plurality of radial channels 162 and radial stops 164 .
- the shaft 156 is sized and routed through the internal channel 125 of the first elongated member 120 such that the distal end 160 is exposed and positioned further distal of the distal end 130 of the first elongated member 120 as illustrated in FIG. 3 .
- FIG. 3 illustrates a detailed assembled perspective view of the distal ends 130 , 160 of the first and second elongated members 120 , 140 , the arm members 180 , and the tension members 210 of the hernia repair system 100 .
- the distal end 160 of the second elongated member 140 is distally positioned to geometrically cap the distal end 130 of the first elongated member 120 .
- the geometric capping configuration includes aligning the radial curvatures and diameters of the distal ends 130 , 160 .
- the radial relative position of the distal ends 130 , 160 with respect to one another corresponds to the articulation freedom of the arm members 180 .
- the arm members 180 are distally extended from the arm articulation regions 132 of the first elongated member 120 through the radial channels 162 of the second elongated member 140 . Therefore, the radial channels 162 of the second elongated member 140 are rotationally aligned with the arm articulation regions 132 of the first elongated members 120 , thereby allowing the arm members 180 to articulate distally.
- the operation of the system 100 includes the ability for a user to rotate the second elongated member 140 with respect to the first elongated member 120 , thereby rotating the radial orientations of the distal ends 130 , 160 with respect to one another.
- the illustrated rotational orientation of the distal ends 130 , 160 with respect to one another may be referred to as an unrestricted configuration because of the rotational alignment between the radial channels 162 and arm articulation region 132 .
- FIG. 4 illustrates a detailed assembled perspective view of the distal ends 130 , 160 of the first and second elongated members 120 , 140 , the arm members 180 , and the tension members 210 of the hernia repair system 100 .
- FIG. 4 particularly illustrates the complete length of the arm members 180 including the proximal segment 182 , medial segments 184 , and distal segment 190 .
- One of the arm members 180 is proximally lengthwise articulated including a combined articulation of individual segments 182 , 184 , 190 , and an articulation with respect to the distal end 130 of the first elongated member 120 .
- the illustrated segments 182 , 184 , 190 are intercoupled utilizing a male to female portion intercoupled with a pin 186 .
- the particular moveable coupling scheme between the segments 182 , 184 , 190 will be further described with reference to FIG. 6 .
- the tension members 210 extend lengthwise along the proximal and medial segments 182 , 182 to the distal segment 190 .
- the lengthwise side of the segments 182 , 184 , 190 along which the tension members 210 extend may be described as either the inward side or distal side due to the moveable positioning of the arm members 180 .
- FIGS. 5A-5F illustrate cross-sectional views of the hernia repair system of FIG. 1 along the corresponding axis designations A-A′ through F-F′.
- FIG. 5A illustrates the medial region 150 of the second elongated member 140 disposed within the cylindrical region 125 of the first elongated member 120 .
- the medial region 150 is specifically sized and shaped to facilitate translation within the internal channel 126 of the first elongated member 120 .
- FIG. 5B illustrates the shaft 156 positioned within the threaded region 152 of the second elongated member 140 and the cylindrical region 150 of the first elongated member 120 .
- FIG. 5C illustrates the tension members 210 lengthwise extending along the shaft 156 within the cylindrical region 124 of the first elongated member 120 .
- FIG. 5D illustrates the arm articulation regions 132 , spacer regions 134 , and rotational regions 136 of the distal end 130 of the first elongated member 120 .
- the rotational regions 136 provide a groove that extends circumferentially around the entire distal end 130 which enables the locked configuration of the distal ends 130 , 160 , described in further detail below with reference to FIG. 11 .
- the distal end 160 of the second elongated member 140 is illustrated as extending within the center of the distal end 130 of the first elongated member 120 .
- the tension members 210 are routed radially external to the distal end 130 of the first elongated member 130 .
- FIG. 5E illustrates the channels 162 and stops 164 of the distal end 160 of the second elongated member 140 .
- the tension members 210 are routed radially external to the distal end 160 of the second elongated member 140 .
- FIG. 5F illustrates the orientations of the medial segments 184 of the arm members 180 with respect to the tension members 210 .
- FIG. 6 illustrates a detailed perspective view of the distal segment 190 of a single arm member of the hernia repair system 100 .
- the intercoupling between the medial segment 184 and the distal segment 190 is representative of the intercoupling scheme utilized between the other segments.
- the distal segment 190 includes segment portion 189 with a female region 187 disposed opposite to the distal most end.
- a corresponding male portion 188 of the medial segment 184 is positioned within the female region 187 of the segment portion 189 and coupled via a pin 186 .
- the pin 186 enables a rotational articulation between the medial segments 184 and segment portion 189 of the distal segment 190 .
- the shape of the male and female regions 188 , 187 restrict the relative rotational articulation.
- the female region 187 includes a lengthwise recess only exposed on one lengthwise side (illustrated upward) of the segment portion 187 . Therefore, the opposite side of the segment portion 189 is covered, restricting the male region 188 from rotationally articulating in one direction beyond a substantially lengthwise parallel configuration. The male region 188 therefore is only able to rotate within a substantially ninety degrees of freedom with respect to the female region 187 .
- the distal segment 190 further includes a needle retaining member 192 moveably coupled to the segment portion 189 via a pin 186 on an opposite lengthwise side of the medial segment 184 .
- the needle retaining member 192 includes two recesses 196 , 197 for releasably housing a first and second needle 198 , 199 respectively.
- the tension members 210 are rigidly coupled to the needle retaining member 192 via a tab 194 .
- the moveable coupling of the needle retaining member 192 enables a substantially ninety degree rotational freedom of the needle retaining member 192 with respect to the segment portion 189 .
- the articulation position of the needle retaining member 192 with respect to the segment portion 189 is determined in part by the tension on the tension member 210 .
- the needles 198 , 199 are coupled to a first and second suture 201 , 202 to facilitate coupling the mesh (not shown) over the distal side of a herniated region.
- FIG. 7 illustrates a profile view of the proximal ends 122 , 142 of the first and second elongated member 120 , 140 of the hernia repair system 100 in an assembled configuration.
- the operation of the system 100 is controlled by the relative positioning of the proximal ends 122 , 142 to enable a user to externally manipulate the distal ends 130 , 160 without unnecessarily invasively exposing the surgical region.
- the proximal end 142 is coupled to the square region 146 of the second elongated member 140 via the locking pin 144 .
- the shape of the square region 146 corresponds to proximal opening to the internal region 126 on the proximal end 122 of the first elongated member 120 .
- the proximal end 122 is coupled to the cylindrical region 124 .
- FIG. 8 illustrates a detailed perspective view of the mesh 205 coupled to the distal side of the arm members 180 in a radially extended configuration of the hernia repair system 100 .
- the mesh 205 is a flexible material designed to cover the hernia defect in a two dimensional fashion.
- Various well known mesh or implant type materials may be utilized in accordance with embodiments of the present invention.
- the mesh 205 includes two sutures 201 , 202 which extend across and around the distal side (not shown) of the mesh 205 to facilitate suturing.
- the sutures 201 , 202 may also be any type of conventional sutures in accordance with embodiments of the present invention.
- the sutures 201 , 202 are coupled to the lengthwise end of the needles 198 , 199 disposed within the recesses of the needle retaining member 192 .
- the needle retaining member 192 is oriented with respect to the segment portion 189 and the arm members 180 such that the needles 198 , 199 are oriented perpendicular to the mesh 205 to enable routing the needles 198 , 199 through the edges of the hernia defect.
- the specific positions of the needle retaining member 192 and overall lengthwise configuration of the arm members 180 corresponds to the tension of the tension members 210 and the relative positioning of the proximal ends 122 , 142 of the first and second elongated member 120 , 140 .
- FIGS. 9A-9B illustrate perspective views of the proximal ends 122 , 142 of the first and second elongated member 120 , 140 corresponding to two different operational states of the hernia repair system 100 .
- FIG. 9A illustrates an unlocked in which the proximal ends 122 , 142 are rotationally aligned with one another.
- the unlocked configuration corresponds to the distal end 160 of the second elongated member 140 being rotationally aligned with the distal end 130 of the first elongated member 120 to enable distal articulation of the arm members 180 , as illustrated in FIGS. 3 and 4 .
- the proximal ends 122 , 142 are translationally disposed adjacent to one another in the unlocked or distal freedom configuration such that the distal-most region of the second elongated member 140 proximal end 142 is adjacent to the proximal-most region of the first elongated member 120 proximal end 122 .
- the unlocked configuration corresponds to a particular rotational alignment of the distal ends 130 , 160 to enable distal articulation of the arm members 180 .
- the particular configuration of the proximal ends 122 , 142 may also be referred to as a distal freedom configuration because the arm members 180 are enabled to lengthwise articulate freely between the radial extended and distal lengthwise extended configurations.
- the system 100 is initially inserted through a trocar with the proximal ends 122 , 142 in the unlocked configuration ( FIG. 9A ) to enable a particular unlocked rotational alignment of the distal ends 160 , 130 ( FIG. 10 ) and the arm members 180 to be positioned within a distal extended configuration ( FIG. 12 ) that is capable of being contained within the diameter of the internal channel of the trocar.
- the tension members 210 are sized and positioned so as to have little or no tension in the unlocked configuration of the proximal ends 122 , 142 . Therefore, the tension members 210 do not exert any substantial tension forces affecting the articulation position of the arm members 180 in the unlocked configuration.
- FIG. 9B illustrates the locked configuration in which the proximal ends 122 , 142 are translationally separated and rotated with respect to one another.
- the second elongated member 140 proximal end 142 is retracted or translated proximally away from the first elongated member 120 proximal end 122 , causing the flat region 146 to extend a particular distance through the proximal opening to the internal channel 126 such that the notch 148 is translationally aligned with the proximal opening.
- the notch 148 of the second elongated member 140 enables the second elongated member 140 to be rotated with respect to the first elongated member 120 within the flat shaped proximal opening of the first elongated member 120 .
- the rotation of the proximal end 142 of the second elongated member 140 corresponds to a rotation of the distal end 160 .
- the direction and degree of rotation between the proximal ends 142 , 122 may be determined by the shape of the notch 148 .
- the notch 148 may be specifically shaped to limit the rotation of the second elongated member 140 to ensure accurate rotational positioning of the distal end 160 of the second elongated member 140 with respect to the distal end 130 of the first elongated member 120 .
- the illustrated extended and rotational position of the proximal ends 142 , 122 corresponds to both tensioning the tension members 210 and rotating the distal end 160 of the second elongated member 140 with respect to the first elongated member 120 .
- the proximal ends 122 , 142 are subsequently manipulated by a user into the locked configuration ( FIG. 9B ) to enable a particular locked rotational alignment of the distal ends 160 , 130 ( FIG. 11 ) that locks the arm members 180 into a radial extended configuration ( FIG. 13 ).
- the radial extended configuration of the system 100 is capable of attaching and suturing the mesh over the herniated region. Since the tension members 210 are rigidly coupled to both the first and second elongated members 120 , 140 , the relative extension or translation causes a tension force in the tension members 210 which will be described further below with reference to FIGS. 11 and 13 .
- FIG. 10 illustrates a detailed perspective view of the distal ends 130 , 160 of the first and second elongated members 120 , 140 in an unlocked configuration of the hernia repair system 100 .
- the unlocked configuration of the distal ends 130 , 160 corresponds to a rotational alignment of the channels 162 with the arm articulation regions 132 .
- the stops 164 are rotationally aligned with the spacer regions 134 . Because of the adjacent positioning of the proximal ends 122 , 142 ( FIG. 9A ), the tension members 210 are not tensioned and therefore do not exert any substantial forces upon the arm members 180 in this configuration.
- the positioning of the distal ends 160 , 130 enables the proximal segments 182 of the arm members 180 to articulate within an approximate ninety degree freedom between a perpendicular (shown) position and a substantially parallel lengthwise position.
- the proximal segments 182 articulate lengthwise within the articulation regions 132 and channels 162 of the distal ends 130 , 160 respectively.
- FIG. 11 illustrates a detailed perspective view of the distal ends 130 , 160 of the first and second elongated members 120 , 140 in a locked configuration of the hernia repair system 100 .
- the second elongated member 140 distal end 160 is rotated with respect to the first elongated member 130 distal end 130 such that the stops 164 are rotationally aligned with the arm members 180 and the arm articulation regions 132 .
- the relative rotational positioning of the distal ends 130 , 160 locks or substantially restricts the articulation freedom of the proximal segment 182 of the arm members 180 into the illustrated radial or perpendicular configuration with respect to the first elongated member 120 .
- the tension members 210 become taut and exert a radially-oriented tension force upon the arm members 180 and effectively restrict the medial and distal segments 184 , 190 into the radially extended configuration FIG. 13 ).
- FIG. 12 illustrates a detailed perspective view of the arm members 180 , mesh 205 , and the distal ends 160 , 130 of the first and second elongated members 120 , 140 in a distal lengthwise extended configuration of the arm members 180 of the hernia repair system 100 .
- the lengthwise extended configuration of the arm members 180 corresponds to the unlocked configurations of the distal and proximal ends 130 , 160 , 122 , 142 of the first and second elongated members 120 , 140 .
- the arm members 180 extend substantially lengthwise away from the distal ends 130 , 160 in a distal direction.
- the mesh 205 is disposed between the arm members 180 .
- the arm members 180 are substantially lengthwise aligned including lengthwise alignment of the proximal, medial, and distal segments 182 , 184 , 190 .
- the unlocked configuration of the distal and proximal ends 130 , 160 , 122 , 142 of the first and second elongated members 120 , 140 corresponds to articulation freedom of the arm members 180 , and therefore they are not locked into the lengthwise extended configuration.
- the tension members 210 are not taut and do not exert any form of tension force upon the arm members 180 into the lengthwise extended configuration.
- the male-female pin type coupling described in detail with reference to FIG.
- the pin retaining members 192 are illustrated in a radial oriented configuration but are capable of articulating such that the needles (not shown) are proximally oriented and lengthwise folded against the corresponding arm members 180 . Therefore, as the system 100 is operationally initially inserted into a trocar, the needles (not shown) extending from the needle retaining members 192 will be forced to articulate proximally to enable lengthwise alignment and system containment within the trocar channel.
- FIG. 13 illustrates a detailed perspective view of the arm members 180 , mesh 205 , and the distal ends 130 , 160 of the first and second elongated members 120 , 140 in a radially extended configuration of the arm members 180 of the hernia repair system 100 .
- the radially extended configuration of the arm members 180 corresponds to the locked configurations of the distal and proximal ends 130 , 160 , 122 , 142 of the first and second elongated members 120 , 140 .
- the arm members 180 are radially extended substantially perpendicular to the first and second elongated members 120 , 140 .
- the corresponding locked configuration of the proximal ends 122 , 142 causes the tension members 210 to be taut, thereby exerting a tension force across the arm members 180 . Because of the routing configuration of the tension members 210 , this causes the arm members 180 to be radially extended with respect to the distal ends 130 , 160 .
- the mesh 205 is positioned on the distal side of the arm members 180 .
- the tension members 210 are directly coupled to the needle retaining members 192 , and therefore the tension force also causes the needle retaining members 192 to orient the needles proximally substantially perpendicular to the arm members 180 .
- the arm members 180 are extended into the radial extended configuration upon being disposed distal of the herniated region such that the mesh 205 may be appropriately positioned on the distal side of the entire herniated region.
- the orientation of the needles 201 , 202 enables a user to then retract the entire system and cause the needles to pierce the fascial edges around the herniated region to enable external suturing of the mesh 205 over the herniated region.
- FIG. 14 illustrates a detailed perspective view of the arm members 180 and the distal ends 130 , 160 of the first and second elongated members 120 , 140 in a partially refracted configuration of the hernia repair system 100 .
- the illustrated partially retracted configuration corresponds to the unlocked configurations of the distal and proximal ends 130 , 160 , 122 , 142 of the first and second elongated members 120 , 140 .
- the arm members 180 are illustrated in a partially articulated configuration representing the process through which the arm members 180 are retracted from between the herniated region and the mesh 205 .
- the articulation freedom of the arm members in the unlocked configurations enables the individual segments 182 , 184 , 190 of each arm member to articulate proximally lengthwise to correspond to the extraction position. Therefore, the arm members 180 may be retracted from a narrow region contained between the mesh 205 and the hernia.
- systems in accordance with the present invention may be utilized to insert and attach a mesh over the distal side of a herniated region via the herniated opening itself.
- a trocar is positioned through the herniated opening so as to provide a proximal to distal channel extending externally to internally.
- the system 100 is in the unlocked configurations ( FIGS. 9A and 10 ) of the distal and proximal ends 130 , 160 , 122 , 142 of the first and second elongated members 120 , 140 , including a substantially distal extended configuration of the arm members 180 ( FIG. 13 ).
- the system 100 is initially translationally distally inserted by a user through the internal channel of a trocar until the arm members 180 and distal ends 130 , 160 are distal to the hernia.
- An optional telescoping sleeve may be utilized to contain the arm members 180 within the distal extended configuration ( FIG. 12 ) during insertion.
- the optional sleeve may then be automatically or manually telescopically retracted proximally from the arm members 180 and distal ends 130 , 160 once the arm members 180 and distal ends 130 , 160 are distally disposed with respect to the hernia.
- the user may then proximally retract and subsequently rotate the second elongated member 140 proximal end 142 from the first elongated member 120 proximal end 122 causing engagement of the locked configurations ( FIGS. 9B and 11 ) and substantial locking of the arm members 180 into the radial extended configuration ( FIG. 14 ).
- the user may then proximally translate the entire system 100 so as to extend the needles 198 , 199 through the abdominal wall around the herniated region and position the mesh 205 over the distal side of the herniated region.
- the needles may then be externally interwoven to suture the mesh 205 .
- Various needle release systems may be utilized to release the needles from the needle retaining members.
- the user may then oppositely rotate and subsequently distally translate the second elongated member 140 proximal end 142 with respect to the first elongated member 120 proximal end 122 , disengaging the locked configurations into the unlocked configurations ( FIGS. 9A and 10 ) of the distal and proximal ends 130 , 160 , 122 , 142 of the first and second elongated members 120 , 140 .
- the reverse rotation is oriented opposite to the rotation used to engage the locked configurations.
- the unlocked configurations enable the segments 182 , 184 , 190 of the arm members 180 to independently articulate within a lengthwise proximal orientation.
- the user then proximally retracts the system 100 from between the mesh 205 and the herniated region.
- the segments 182 , 184 , 190 translate into the internal channel of the trocar, they are forced to individually articulate by varying degrees to enable the retraction.
- the arm members 180 are thereby proximally lengthwise articulated from the radial extended configuration back to the lengthwise distal extended configuration over the course of the retraction process.
- FIG. 15 illustrates a perspective view of an alternative hernia repair system, designated generally at 500 .
- the illustrated system 500 incorporates multiple alternative configurations which may be used individually or in conjunction to form alternative embodiments.
- the system 500 includes a first and second elongated member similar to the system 100 illustrated in FIGS. 1 and 2 .
- the second elongated member 330 is slidably coupled within the first elongated member 320 .
- the external first elongated member 320 further includes a rotational guide indicator 325 , an elongated member 310 , and a stopper 315 .
- the illustrated first and second members 320 , 330 include the proximal handles on the left and distal ends on the right.
- the illustrated system 500 further includes an optional snare system including a wire with loops 370 , a spring-biased clamp 350 , and a pull handle 360 .
- the wire extends through an internal channel of the second elongated member 330 and the spring-biased clamp 350 .
- the wire includes the loop 370 on the distal end and the pull handle region 360 on the proximal end.
- the system further includes an optional guide system of a radial clamping member 250 , including an internal clamping member 280 and a radial surface 260 , 270 .
- the optional independent systems illustrated in FIG. 15 will be described below in further detail.
- FIGS. 16-19 illustrate acts related to the coupling of an independent mesh and suture to the alternative system illustrated in FIG. 15 .
- various mesh and suture configurations may be utilized to provide flexibility in mesh type and suture type used.
- One specific mesh 305 and suture 420 embodiment provides modular coupling schemes on the distal segments 390 of each of the arm members 380 to facilitate independent or commercial suture 420 and/or mesh 305 coupling.
- the use of commercially available mesh 305 and sutures 420 provides flexibility in system use and enables the user to specifically select optimal mesh and suture types for the particular patient. Rather than incorporating preloaded sutures and retracting needles 198 , 199 , 201 , 202 (FIGS.
- each arm member 380 may be configured to each include recesses through which alternative independent sutures 420 may be coupled.
- the recesses may be sized to accept a Keith type needle.
- a snare system 350 , 360 , 370 ( FIG. 15 ) may be incorporated to route the independent suture 420 of a commercial needle-suture pack through the system 500 .
- the snare system 350 , 360 , 370 may include a wire routed through the arm members 380 and through the second elongated member 330 to the proximal handle region as shown in FIG. 15 .
- the path of the wire extends from the distal end through an internal channel of the second elongated member 330 out the proximal handle region of the second elongated member 330 .
- the wire of the snare system 350 , 360 , 370 includes a central loop or coupler 370 disposed on the distal end and a pull handle 360 disposed at the proximal end of the system 500 extending out from the handle.
- the pull handle portion 360 of the wire extends through a spring-biased clamping member 350 for retaining the proximal end of the wire and later the independent sutures external of the second elongated member 330 .
- the system 500 is positioned in the radially extended configuration ( FIG. 16 ) to facilitate the preloading of the independent sutures 420 and mesh 305 .
- the user extends the needles 410 of each commercial needle-suture pack through the recess at the distal segment 390 of each arm member 380 , thereby coupling the sutures to the distal segments 390 .
- the independent mesh 305 is positioned below the radially extended arm members 380 such that the edges of the mesh are substantially aligned with the distal segments 390 of each arm member 380 .
- the user extends the needles 410 of the needle-suture packs through the corresponding portions of the mesh 305 and then through the distal central loop portion 370 of the wire of the snare as shown in FIG. 17 .
- the needles 410 are cut and removed from the sutures 420 .
- the proximal handle portion 360 of the snare system 350 , 360 , 370 is then proximally retracted to route the sutures through the system 500 and circumferentially couple the mesh 305 at the distal segment 390 of each arm member 380 for standard operation as shown in FIG. 18 .
- the snare system 350 , 360 , 370 is fully retracted to cause the sutures 420 to extend through the spring-biased clamping member 350 , thereby loading the independent sutures and mesh 305 on the system 500 as shown in FIG. 19 .
- the snare system 350 , 360 , 370 may be removed, and the system 500 may be reconfigured into the extended configuration ( FIG. 20 ).
- the optional systems and methods described below to confine the arm members 380 and mesh 305 may also be used prior to performing the procedure, including but not limited to confining the arm members 380 and mesh within a sleeve member or manually confining the mesh 305 and arm members 380 as shown in FIG. 21 .
- the system 500 is then inserted and the mesh 305 is deployed in accordance with the procedure described above.
- the user may use the alternative guiding system in combination with standard laparoscopic suture passers to affix the mesh 305 with a second set of independent sutures (not shown).
- the spring-biased clamping member 305 is removed and the first set of mesh coupling sutures 420 are allowed to translate back through the system 500 .
- a second mesh and suture embodiment may include a pre-loaded mesh but facilitate a similar system for enabling a user to couple independent or commercially available sutures.
- FIG. 20 illustrates an optional guiding system disposed over the arm members and mesh, designated generally at 250 .
- various external members may be used to externally guide and/or secure the system 500 and/or trocar with respect to the patient during operation.
- the optional systems may provide an accurate guide to the external locations at which the suturing will occur.
- One embodiment includes incorporating an externally disposed radial clamping member 250 with the system described above, so as to provide a visual guide (i.e. jig) for the user and/or to facilitate stabilizing the system 500 during operation.
- the radial clamping member 250 includes an internal opening 280 and a radial surface 270 , 260 .
- the radial clamping member 250 is externally coupled over an external portion of the outermost member for the particular procedure.
- the radial clamping member is coupled over an external portion of the elongated medial portion of the first elongated member 310 / 120 .
- the radial clamping member is coupled over an external portion of the elongated medial portion of the trocar 200 .
- the internal opening of the radial clamping member is shaped to correspond to the external diameter of either the first elongated member 310 / 120 or the trocar 200 .
- the diameter of the internal opening may be slightly larger, thereby facilitating a slidable radial external coupling.
- the slidable coupling of the radial clamping member 250 enables a user to translate it against the external side of the patient during the procedure to provide both a guide and a stabilizing mechanism.
- the radial clamping member 250 and radially extended arm members 380 may effectively sandwich against the proximal and distal sides of the hernia to provide stability during the mesh coupling procedure.
- the internal opening may also include a clamping system to secure the radial clamping member to a particular region of the first elongated member 310 / 120 or trocar 200 throughout the procedure.
- Various clamping systems may be utilized, including but not limited to levers, compliant springs, etc.
- the radial surface 260 , 270 extends radially from the internal opening.
- the illustrated radial surface 260 , 270 includes a plurality of radial distance indicators 270 to illustrate alternative mesh diameter distances.
- the illustrated radial surface 260 , 270 also includes a quadrant member 270 to indicate four radial distance positions.
- the internal opening is disposed substantially within the center of the radial surface.
- the radial surface 260 , 270 is substantially orthogonal to the lengthwise orientation of the system 500 / 100 and the trocar 200 ( FIGS. 16 , 18 , and 19 ). Therefore, the radial surface 260 , 270 is also configured to be substantially parallel to the mesh 305 and arm members 380 in the radial extended configuration ( FIG.
- the radial surface 260 , 270 includes a substantial two dimensional area corresponding to the mesh 305 and arm members 380 in the radial extended configuration ( FIG. 20 ).
- the radial surface 260 , 270 may include a plurality of suture indicators to provide a reliable external guide as to the location of the internal sutures.
- FIG. 21-22 illustrate optional confinement systems for confining the arm members and mesh in accordance with embodiments of the present invention.
- the described optional confinement systems may be used in conjunction with the embodiment described in reference to FIGS. 1-14 , the alternative embodiment illustrated in FIG. 15 , or any combination thereof.
- the optional confinement systems for the arm members and mesh may be utilized prior to insertion of the system 100 within a trocar 200 or other incision.
- a first arm member and mesh confinement procedure embodiment may include using a sleeve member (not shown) to radially compress and confine the mesh 305 and arm members 380 in the unlocked extended configuration ( FIGS. 15 and 22 ), thereby loading the system.
- the sleeve member may be a cylindrically shaped hollow region comprising an elastic material having a diameter wider than the elongated portion 310 of the first elongated member 320 .
- a mesh 305 may be coupled to the arm members 180 as described above. Subsequently, the sleeve member may be translated over the arm members 180 , thereby retaining the arm members 180 and mesh within the internal region of the sleeve member in an elongated configuration.
- the second elongated member 330 may be proximally translated away from the first elongated member 320 by a particular distance, causing the distal end of the second elongated member 320 including the arm members 380 and mesh 305 to be partially retracted internally within the first elongated member 320 .
- the relative diameter of the sleeve member with respect to the first elongated member 320 will cause the sleeve member to separate from the arm members 180 and mesh 205 and independently translate externally over the first elongated member 320 .
- the partial external translation of the sleeve member over the first elongated member 320 will thereby engage the sleeve member with the first elongated member 320 while substantially confining the arm members 380 and mesh 305 within a particular radial elongated region.
- the particular amount of translation of the sleeve member over the first elongated member 320 could be biased or stopped by an O-ring or other semi-compressible region of the sleeve member.
- similar O-ring and semi-compressible regions could be used to induce a particular amount of resistance as the sleeve member is partially translated externally over the first elongated member.
- Various other tactile feedback systems may also be incorporated to provide the user with guidance toward optimal translation.
- a second arm member and mesh confinement procedure embodiment may eliminate the sleeve member.
- the mesh 305 is coupled to the arm members 380 via one of the procedures described above.
- the mesh 305 and arm members 380 are then manually confined within a radial configuration ( FIG. 21 ) and inserted directly into a trocar or incision.
- These alternative embodiments facilitate the efficient insertion of the arm members 380 and mesh 305 within a standard diameter trocar or other incision.
- the containment or radial confinement of the arm members 380 and mesh 305 enable the use of thicker mesh materials which may otherwise obstruct or impede the insertion of the system within a standard trocar.
- the remaining components of the system may be the same as that described above.
- the remaining acts of the hernia repair procedure may also be the same as that described above.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Cardiology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Vascular Medicine (AREA)
- Pathology (AREA)
- Prostheses (AREA)
- Surgical Instruments (AREA)
Abstract
One embodiment of the present invention relates to a minimally invasive implant-based ventral hernia repair system including a first and second elongated member in which the second elongated member extends through the internal channel of the first elongated member. A set of arm members are moveably coupled to the distal end of the first elongated member. A set of tension members extends lengthwise along the arm members and is rigidly coupled between the distal most segment of each arm member and the second elongated member. The degree of tension in the tension members corresponds to the configuration of the arm members with respect to the first elongated member. The proximal translation of the second elongated with respect to the first elongated member causes tension on the tension members, which thereby articulates the arm members into a radial extended configuration in which the arm members extend radially and substantially perpendicular to the first elongated member.
Description
This is a continuation in part application claiming priority to U.S. utility application Ser. No. 12/418,579 filed Apr. 4, 2009, the contents of which are incorporated by reference.
FIELD OF THE INVENTIONThe invention generally relates to minimally invasive hernia repair systems. In particular, the present invention relates to a minimally invasive implant-based ventral hernia repair system and method of operation.
BACKGROUND OF THE INVENTIONA hernia is a weakness in a particular anatomical surface which allows an internally contained organ to protrude. Ventral hernias are a type of hernia resulting primarily from weaknesses in the abdominal wall. Hernias of the groin region, or inguinal hernias, are a separate type of abdominal wall hernia which are repaired with a different subset of surgical equipment and techniques. Repair of ventral hernia defects conventionally utilized open primary sutured repair. However, recurrence rates of ventral hernias after an open primary suture procedure were determined to be unacceptably high. Open mesh repair utilizes a synthetic or biologic mesh to correct the hernia but is still performed as an open invasive procedure. Open mesh repair has recently been replaced by laparoscopic, or minimally invasive, mesh repair. Recurrence rates have been shown to be lower after laparoscopic ventral hernia repair with respect to open repair. Laparoscopic type hernia repair reduces dissection and destruction of the structurally important fascial layers of the abdominal wall via the use of small incisions in the fascia, through which trocars are placed for instrumentation. Unfortunately, even small (i.e. 5 mm) incisions can potentially develop into new hernias, especially in patients with a demonstrated propensity to developing fascial breakdown. Therefore, fewer trocars utilized to perform an operation generally results in a lower recurrence rate. Conventional laparoscopic surgical techniques for ventral hernia repair commonly require up to six trocars and corresponding incisions for proper manipulation of instruments and mesh implants.
Therefore, there is a need in the industry for systems and methods that reduce the number of trocars necessary for minimally invasive implant-based ventral hernia repair.
SUMMARY OF THE INVENTIONThe invention generally relates to minimally invasive hernia repair systems. One embodiment of the present invention relates to a minimally invasive implant-based ventral hernia repair system. The system includes a first elongated member with an internal channel extending between a distal and proximal opening. A second elongated member extends through the internal channel of the first elongated member. A set of arm members is moveably coupled to the distal end of the first elongated member such that the arm members have a restricted freedom of movement with respect to the first elongated member. The arm members each include a set of lengthwise moveably intercoupled segments. A set of tension members extends lengthwise along the arm members and is rigidly coupled between the distal most segment of each arm member and the second elongated member. The degree of tension in the tension members corresponds to the configuration of the arm members with respect to the first elongated member. The proximal translation of the second elongated with respect to the first elongated member causes tension on the tension members, which thereby articulates the arm members into a radial extended configuration in which the arm members extend radially and substantially perpendicular to the first elongated member. A mesh is releasably coupled to the distal side of the arm members to facilitate coupling over the corresponding hernia. The moveable couplings between the arm members and the first elongated member and between the intercoupled segments of the arm members facilitates a restricted lengthwise freedom of movement that enables the system to be coupled to the mesh over the hernia and to be removable from between the mesh and hernia. A second embodiment of the present invention relates to a method of distally coupling a mesh over a ventral hernia in the abdominal wall and subsequently removing the remainder of the hernia repair system.
Embodiments of the present invention represent a significant advancement in the field of ventral hernia repair. Conventional minimally invasive ventral hernia repair systems and procedures utilize multiple instruments and openings in the abdominal wall to position and suture a mesh or implant over the hernia. Embodiments of the present invention provide a self-contained system for hernia mesh deployment and suturing through the hernia opening itself. The unique selectively restricted movement freedom of the arm members enables the system to be inserted through the internal channel of a trocar, coupled with a mesh over the distal opening of a hernia, and the remainder removed from between the mesh and hernia. This presents an advantage because the number of abdominal wall openings made in a hernia repair procedure has been determined to directly correspond to hernia recurrence rate.
These and other features and advantages of the present invention will be set forth or will become more fully apparent in the description that follows and in the appended claims. The features and advantages may be realized and obtained by means of the instruments and combinations particularly pointed out in the appended claims. Furthermore, the features and advantages of the invention may be learned by the practice of the invention or will be obvious from the description, as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGSThe following description of the invention can be understood in light of the Figures, which illustrate specific aspects of the invention and are a part of the specification. Together with the following description, the Figures demonstrate and explain the principles of the invention. In the Figures, the physical dimensions may be exaggerated for clarity. The same reference numerals in different drawings represent the same element, and thus their descriptions will be omitted.
illustrates a perspective view of a hernia repair system and corresponding trocar in accordance with one embodiment of the present invention;
illustrates an exploded view of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the distal end of the first and second elongated members of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the arm members and the distal ends of the first and second elongated members of the hernia repair system illustrated in
FIG. 1;
illustrate cross-sectional views of the hernia repair system of
FIG. 1along the corresponding axis A-A′ through F-F′;
illustrates a detailed perspective view of the distal segment of a single arm member of the hernia repair system illustrated in
FIG. 1;
illustrates a profile view of the proximal ends of the first and second elongated member of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the mesh coupled to the distal side of the arm members of the hernia repair system illustrated in
FIG. 1;
illustrate perspective views of the proximal ends of the first and second elongated member corresponding to two different operational states of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the distal ends of the first and second elongated members in an unlocked configuration of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the distal ends of the first and second elongated members in a locked configuration of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the arm members, mesh, and the distal ends of the first and second elongated members in a distal lengthwise extended, or undeployed configuration of the arm members of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the arm members, mesh, and the distal ends of the first and second elongated members in a radial extended configuration of the arm members of the hernia repair system illustrated in
FIG. 1;
illustrates a detailed perspective view of the arm members and the distal ends of the first and second elongated members in a partially refracted configuration of the hernia repair system illustrated in
FIG. 1;
illustrates a perspective view of an alternative hernia repair system incorporating multiple independent alternative configurations;
illustrate coupling acts of an independent mesh and suture to the alternative system illustrated in
FIG. 15;
illustrates an optional guiding system disposed over the arm members and mesh;
illustrate optional confinement procedures for confining the arm members and mesh in accordance with embodiments of the present invention.
The invention generally relates to minimally invasive hernia repair systems. One embodiment of the present invention relates to a minimally invasive implant-based ventral hernia repair system. The system includes a first elongated member with an internal channel extending between a distal and proximal opening. A second elongated member extends through the internal channel of the first elongated member. A set of arm members is moveably coupled to the distal end of the first elongated member such that the arm members have a restricted freedom of movement with respect to the first elongated member. The arm members each include a set of lengthwise moveably intercoupled segments. A set of tension members extends lengthwise along the arm members and is rigidly coupled between the distal most segment of each arm member and the second elongated member. The degree of tension in the tension members corresponds to the configuration of the arm members with respect to the first elongated member. The proximal translation of the second elongated with respect to the first elongated member causes tension on the tension members, which thereby articulates the arm members into a radial extended configuration in which the arm members extend radially and substantially perpendicular to the first elongated member. A mesh is releasably coupled to the distal side of the arm members to facilitate coupling over the corresponding hernia. The moveable couplings between the arm members and the first elongated member and between the intercoupled segments of the arm members facilitates a restricted lengthwise freedom of movement that enables the system to be coupled to the mesh over the hernia and to be removable from between the mesh and hernia. A second embodiment of the present invention relates to a method of distally coupling a mesh over a ventral hernia in the abdominal wall and subsequently removing the remainder of the hernia repair system. Also, while embodiments are described in reference to ventral hernia repair, it will be appreciated that the teachings of the present invention are applicable to other areas. For example, embodiments and teachings of the present invention may be utilized to repair other types of hernias.
The following terms are defined as follows:
Endoscopic surgery—broadly defined to include all minimally invasive surgical procedures, including but not limited to laparoscopy, thoracoscopy and arthroscopy.
Hernia—a weakness or recess in a particular anatomical surface which allows an internally contained organ to protrude. The internal side of the herniated surface is referred to herein as the distal side. The external side of the herniated surface is referred to herein as the proximal side. A particular type of hernia referred to as a ventral hernia involves a weakness in the abdominal wall.
Trocar—a cylindrical device which may be inserted through a surgical incision to provide a channel through a body wall to the intended internal surgical region.
Distal—an anatomical surgical reference term used herein to refer to a region toward the body of the patient. For example, a trocar disposed within a patient is oriented such that the distal end is disposed within the surgical field and/or the patient's body.
Proximal—an anatomical surgical reference term used herein to refer to a region away from the body of the patient. For example, a trocar disposed within a patient is oriented such that the proximal end is disposed external to the patient's body.
Mesh—a general term used to describe any synthetic or biologic implant configured to extend over and cover the internal opening/weakness of a hernia.
Needle—a general term used to describe any suture device configured to couple a mesh over a hernia.
Needle-suture pack—any type of independently prepared package including a needle pre-coupled to a suture.
Laparoscopic suture passer—a type of transfacial suturing device that enables external suturing independent of the main system or trocar.
Spring-biased clamp—a clamping member including a releasable opening biased toward a closed position.
Reference is initially made to
FIG. 1, which illustrates a perspective view of a hernia repair system and corresponding trocar, designated respectively at 100 and 200. Minimally invasive hernia repair procedures initially include inserting a trocar through the herniated surface, thereby creating a proximal to distal channel through the hernia in the abdominal wall. The trocar provides an access channel through which instruments may be inserted distal to the hernia. Conventional laparoscopic hernia repair procedures require the insertion of additional trocars in the vicinity of the hernia to enable additional instruments to access the distal side of the herniated surface. Embodiments of the present invention include a system that is designed to operate exclusively through a
single trocar200 positioned through the hernia. The illustrated
hernia repair system100 is configured to be inserted through the internal channel of the
trocar200 onto the distal side of the hernia so as to expand and implant a repair mesh over the hernia. The illustrated
trocar200 is for reference purposes only, and it will be appreciated that the illustrated embodiment may be utilized with other trocars.
The
hernia repair system100 includes a first
elongated member120, a second
elongated member140, a plurality of
tension members210, and a plurality of
arm members180. The illustrated first elongated
member120 is cylindrically shaped with a particular external diameter and curvature corresponding to the diameter of the internal channel of the illustrated
trocar200. It will be appreciated that various diameters and shapes may be utilized in accordance with embodiments of the present invention. In addition, the external surface of the first
elongated member120 is configured to facilitate a smooth translation within the internal channel of the
trocar200. The first
elongated member120 is illustrated with a distal end oriented towards the left and a proximal end oriented to the right. The plurality of
arm members180 are moveably coupled to the distal end of the first
elongated member120. The plurality of
arm members180 are distally extended and capable of three dimensionally conforming to the diameter of the internal channel of the
trocar200. The second
elongated member140 is lengthwise extended through the first
elongated member120. The second
elongated member140 is illustrated with a distal end towards the left and a proximal end oriented to the right. The operation, assembly, and technical specifications of each of the components of the
hernia repair system100 will be described further in reference to the subsequent figures.
Reference is next made to
FIG. 2, which illustrates an exploded view of the
hernia repair system100. The
hernia repair system100 generally includes a first
elongated member120, a second
elongated member140, a plurality of
arm members180, and a plurality of
tension members210. The first
elongated member120 includes a
cylindrical region124, a
proximal end122, an
internal channel125, and a
distal end130. The
cylindrical region124 is an elongated hollow member which may be composed of a rigid metal material such as stainless steel or aluminum. The
cylindrical region124 is positioned between the proximal and
distal ends122, 130 of the first
elongated member120. The
internal channel125 extends lengthwise within the
cylindrical region124. The particular external shape, diameter, and surface texture of the
cylindrical region124 are configured to correspond to the diameter of the internal channel of a trocar. The
proximal end122 includes a dual recess handle shaped region to facilitate operation. It will be appreciated that various handle shapes may be utilized to accommodate different functionalities. The illustrated dual recess shape provides a surface upon which a user's fingers may oppose a distal or proximal oriented thumb force upon the second
elongated member140 with respect to the first
elongated member120. The illustrated handle shaped region is coupled to the cylindrical region via a recess within which the
cylindrical region124 is extended. The handle region may be composed of a rigid plastic composite material. The
internal channel125 extends through the
proximal end122 and handle shaped region to a proximal opening on a proximally oriented surface of the
proximal end122. The
distal end130 includes a
coupler region128 moveably coupled to the plurality of
arm members180. The
coupler region128 includes a plurality of radially oriented
recesses126, a plurality of radially oriented arm
member articulation regions132, and a plurality of radially oriented
spacer regions134. The
internal channel125 extends through the
distal end130 to a distal opening on a distal oriented surface. The plurality of
arm members180 are moveably coupled to the
distal end130 so as to facilitate a restricted freedom of movement radially oriented within the arm
member articulation regions132. The
spacer regions134 radially space the articulation of the
arm members180 from one another. The illustrated shape of the distal end is substantially cylindrical to maintain total system conformity to within the diameter of the internal trocar channel in a particular distal extended configuration. A smaller diameter region is positioned between the
cylindrical region124 and the arm
member articulation region132. The smaller diameter region provides a transition region for the
tension members210 to extend between the
internal channel125 and the
arm members180 without radially extending beyond the diameter corresponding to the internal channel of a
trocar200. The
recesses126 are disposed in the smaller diameter region and extend between the exterior and the
internal channel125.
The
arm members180 are moveably coupled to the
distal end130 of the first
elongated member120 to limit the articulation of the
arm members180 between a lengthwise extended distal configuration (
FIG. 12) and a radial extended configuration (
FIG. 13). The particular coupling between the
distal end130 and the
arm members180 may utilize a pin type connection oriented across and through the arm
member articulation regions132 and the
arm members180 so as to facilitate a substantially lengthwise (proximal to distal) oriented articulation. The shape and positioning of the pin with respect to the
arm members180 and the arm
member articulation regions132 will restrict the lengthwise freedom of articulation of the
arm members180 to within 180 degrees. The
arm members180 further include a plurality of intercoupled segments including a
proximal segment182,
medial segments184, and a
distal segment190. Configuration and specifications of the segments will be described in more detail with reference to subsequent figures. The intercoupled segments are moveably coupled to one another in a configuration that restricts relative lengthwise articulation to within 90 degrees between individual segments. The intercoupled segments may utilize a
male region188,
female region187, and a
pin186 extending perpendicular as illustrated and described further in reference to
FIG. 6. The restricted moveable couplings between the
distal end130 and the
proximal segment182, and between the
individual segments182, 184, 190 operate to restrict the overall articulation freedom of the
arm members180 to between the lengthwise extended distal configuration (
FIG. 12) and the radial extended configuration (
FIG. 12). Various types of analogous restricted moveable coupling schemes may be utilized in accordance with embodiments of the present invention.
A plurality of
tension members210 are rigidly coupled to and extending between the
distal segment190 of each of the
arm members180 and the second
elongated member140. The
tension members210 may be any type of lengthwise substantially flexible member including but not limited to cables, sutures, threads, wires, etc. The tension members extend substantially lengthwise along the segments of the
arm members180, through the
recesses126 in the
distal end130 of the first
elongated member120 to the internal channel of the first elongated member, and are coupled to the second
elongated member140. The length and relative tension of the
tension members210 corresponds to the configuration of the plurality of
arm members180 with respect to the first
elongated member120. The
tension members210 extend substantially along the distal oriented side of the segments of the
arm members180 if the
arm members180 are positioned in the radially extended configuration (
FIG. 12). The
tension members210 extend from the
recesses126 through a hole on a proximally oriented side of the
proximal segment182 in the smaller diameter region of the
distal end130 of the first
elongated member120. The coupling and length of the
tension members210 with respect to the second
elongated member140 are configured such that there is no tension if the
proximal end144 of the second elongated member is adjacent to the
proximal end122 of the first elongated member 120 (
FIG. 7).
With continued reference to
FIG. 2, the second
elongated member140 includes a
proximal end142, a
locking pin144, a
flat region146, a
notch148, an O-
ring141, a
medial region150, a
washer151, a threaded
region152, a
nut143, a
shaft156, and a
distal end160. As described above, the majority of the second
elongated member140 is disposed within the
internal channel125 of the first
elongated member120 during operation, with the exception of the proximal and
distal ends142, 160. The
proximal end142 includes a single recess curved handle shaped region. It will be appreciated that various handle shapes may be utilized to accommodate different functionalities. The illustrated single recess shape provides a surface upon which a user's thumb may exert a distal or proximal oriented thumb force upon the second
elongated member140 with respect to the first
elongated member120. The operational movement between the proximal ends 122, 142 of the first and second
elongated members120, 140 is in part analogous to the operation of a syringe. The
proximal end142 is operationally coupled over a corresponding cylindrical portion of the
medial region150 via the
pin144. The
flat region146 and notch 148 are shaped to facilitate an operational locking of the second
elongated member140 in a particular proximally translated and rotated position with respect to the first elongated member 120 (
FIG. 9B). The shape of the
flat region146 and notch 140 correspond to the shape of the proximal opening to the
internal channel125 on the
proximal end122 of the first
elongated member120. The O-
ring141 is a rubber circular member circumscribing the
medial region150 to facilitate a smooth operational translation between the first and second
elongated members120, 140. The O-
ring141 may also be configured to include an airtight wax, rubber, or grease seal to form a seal therebetween that prevents leakage and release of the intra-abdominal insufflation gas required to maintain a pneumoperitoneum for operative working space. The
medial region150 is a partially cylindrical region externally shaped to correspond to the
internal channel125 of the first
elongated member120. The
rubber washer151 and
nut143 provide a compression type coupling scheme between the
tension members210 and the second
elongated member140. In an assembled configuration (not shown), the
tension members210 extend along
grooves154 in the threaded
region152 and are compression coupled to the medial region via the
rubber washer151 and the
nut143. It will be appreciated that other types of coupling systems may be utilized between the
tension members210 and the second
elongated member140. The
shaft156 includes a non-circular cross-sectional shape so as to facilitate rotational binding with the remainder of the second
elongated member140. The illustrated
shaft156 is square shaped and disposed within a corresponding square recess within the threaded
region152 so as to enable rotational coordination between the
proximal end142 and the
distal end160 of the second
elongated member140. The proximal end of the
shaft156 is releasably disposed and/or coupled within the square recess of the threaded
region152. This configuration enables lengthwise translational separation between the
shaft156 and the threaded
region152 as the second
elongated member140 is proximally translated with respect to the first
elongated member120. The
distal end160 is directly coupled to the
shaft156 via a welding or adhesive type coupling. The
distal end160 may also be referred to as a locking member in that it functions to selectively lock the articulation freedom of the
proximal segment182 of the
arm members180. The
distal end160 of the second
elongated member140 includes the illustrated threaded male region that couples within a corresponding female threaded region on the
distal end130 of the first
elongated member120. The corresponding coupling between the threaded regions obstructs translational freedom but enables rotational freedom between the distal ends 130, 160 of the first and second
elongated members120, 140. The
distal end160 includes a plurality of
radial channels162 and radial stops 164. In an operational configuration, the
shaft156 is sized and routed through the
internal channel125 of the first
elongated member120 such that the
distal end160 is exposed and positioned further distal of the
distal end130 of the first
elongated member120 as illustrated in
FIG. 3.
Reference is next made to
FIG. 3, which illustrates a detailed assembled perspective view of the distal ends 130, 160 of the first and second
elongated members120, 140, the
arm members180, and the
tension members210 of the
hernia repair system100. The
distal end160 of the second
elongated member140 is distally positioned to geometrically cap the
distal end130 of the first
elongated member120. The geometric capping configuration includes aligning the radial curvatures and diameters of the distal ends 130, 160. In addition, the radial relative position of the distal ends 130, 160 with respect to one another corresponds to the articulation freedom of the
arm members180. In the illustrated configuration, the
arm members180 are distally extended from the
arm articulation regions132 of the first
elongated member120 through the
radial channels162 of the second
elongated member140. Therefore, the
radial channels162 of the second
elongated member140 are rotationally aligned with the
arm articulation regions132 of the first
elongated members120, thereby allowing the
arm members180 to articulate distally. As will be discussed in more detail below, the operation of the
system100 includes the ability for a user to rotate the second
elongated member140 with respect to the first
elongated member120, thereby rotating the radial orientations of the distal ends 130, 160 with respect to one another. The illustrated rotational orientation of the distal ends 130, 160 with respect to one another may be referred to as an unrestricted configuration because of the rotational alignment between the
radial channels162 and
arm articulation region132.
Reference is next made to
FIG. 4, which illustrates a detailed assembled perspective view of the distal ends 130, 160 of the first and second
elongated members120, 140, the
arm members180, and the
tension members210 of the
hernia repair system100.
FIG. 4particularly illustrates the complete length of the
arm members180 including the
proximal segment182,
medial segments184, and
distal segment190. One of the
arm members180 is proximally lengthwise articulated including a combined articulation of
individual segments182, 184, 190, and an articulation with respect to the
distal end130 of the first
elongated member120. The illustrated
segments182, 184, 190 are intercoupled utilizing a male to female portion intercoupled with a
pin186. The particular moveable coupling scheme between the
segments182, 184, 190 will be further described with reference to
FIG. 6. The
tension members210 extend lengthwise along the proximal and
medial segments182, 182 to the
distal segment190. The lengthwise side of the
segments182, 184, 190 along which the
tension members210 extend may be described as either the inward side or distal side due to the moveable positioning of the
arm members180.
Reference is next made to
FIGS. 5A-5F, which illustrate cross-sectional views of the hernia repair system of
FIG. 1along the corresponding axis designations A-A′ through F-F′.
FIG. 5Aillustrates the
medial region150 of the second
elongated member140 disposed within the
cylindrical region125 of the first
elongated member120. The
medial region150 is specifically sized and shaped to facilitate translation within the
internal channel126 of the first
elongated member120.
FIG. 5Billustrates the
shaft156 positioned within the threaded
region152 of the second
elongated member140 and the
cylindrical region150 of the first
elongated member120. In addition, the
tension members210 are routed through the
grooves154 of the threaded
region152. The
tension members210 are circumscribed and compression coupled to the threaded
region152 by the
nut143. The
nut143 is correspondingly internally threaded to couple over the threaded
region152.
FIG. 5Cillustrates the
tension members210 lengthwise extending along the
shaft156 within the
cylindrical region124 of the first
elongated member120.
FIG. 5Dillustrates the
arm articulation regions132,
spacer regions134, and
rotational regions136 of the
distal end130 of the first
elongated member120. The
rotational regions136 provide a groove that extends circumferentially around the entire
distal end130 which enables the locked configuration of the distal ends 130, 160, described in further detail below with reference to
FIG. 11. The
distal end160 of the second
elongated member140 is illustrated as extending within the center of the
distal end130 of the first
elongated member120. In addition, the
tension members210 are routed radially external to the
distal end130 of the first
elongated member130.
FIG. 5Eillustrates the
channels162 and stops 164 of the
distal end160 of the second
elongated member140. Likewise, the
tension members210 are routed radially external to the
distal end160 of the second
elongated member140.
FIG. 5Fillustrates the orientations of the
medial segments184 of the
arm members180 with respect to the
tension members210.
Reference is next made to
FIG. 6, which illustrates a detailed perspective view of the
distal segment190 of a single arm member of the
hernia repair system100. The intercoupling between the
medial segment184 and the
distal segment190 is representative of the intercoupling scheme utilized between the other segments. The
distal segment190 includes
segment portion189 with a
female region187 disposed opposite to the distal most end. A corresponding
male portion188 of the
medial segment184 is positioned within the
female region187 of the
segment portion189 and coupled via a
pin186. The
pin186 enables a rotational articulation between the
medial segments184 and
segment portion189 of the
distal segment190. In addition, the shape of the male and
female regions188, 187 restrict the relative rotational articulation. The
female region187 includes a lengthwise recess only exposed on one lengthwise side (illustrated upward) of the
segment portion187. Therefore, the opposite side of the
segment portion189 is covered, restricting the
male region188 from rotationally articulating in one direction beyond a substantially lengthwise parallel configuration. The
male region188 therefore is only able to rotate within a substantially ninety degrees of freedom with respect to the
female region187. The
distal segment190 further includes a
needle retaining member192 moveably coupled to the
segment portion189 via a
pin186 on an opposite lengthwise side of the
medial segment184. The
needle retaining member192 includes two
recesses196, 197 for releasably housing a first and
second needle198, 199 respectively. In addition, the
tension members210 are rigidly coupled to the
needle retaining member192 via a
tab194. The moveable coupling of the
needle retaining member192 enables a substantially ninety degree rotational freedom of the
needle retaining member192 with respect to the
segment portion189. As will be described in further detail below, the articulation position of the
needle retaining member192 with respect to the
segment portion189 is determined in part by the tension on the
tension member210. The
needles198, 199 are coupled to a first and
second suture201, 202 to facilitate coupling the mesh (not shown) over the distal side of a herniated region.
Reference is next made to
FIG. 7, which illustrates a profile view of the proximal ends 122, 142 of the first and second
elongated member120, 140 of the
hernia repair system100 in an assembled configuration. The operation of the
system100 is controlled by the relative positioning of the proximal ends 122, 142 to enable a user to externally manipulate the distal ends 130, 160 without unnecessarily invasively exposing the surgical region. The
proximal end142 is coupled to the
square region146 of the second
elongated member140 via the
locking pin144. The shape of the
square region146 corresponds to proximal opening to the
internal region126 on the
proximal end122 of the first
elongated member120. The
proximal end122 is coupled to the
cylindrical region124.
Reference is next made to
FIG. 8, which illustrates a detailed perspective view of the
mesh205 coupled to the distal side of the
arm members180 in a radially extended configuration of the
hernia repair system100. The
mesh205 is a flexible material designed to cover the hernia defect in a two dimensional fashion. Various well known mesh or implant type materials may be utilized in accordance with embodiments of the present invention. The
mesh205 includes two
sutures201, 202 which extend across and around the distal side (not shown) of the
mesh205 to facilitate suturing. The
sutures201, 202 may also be any type of conventional sutures in accordance with embodiments of the present invention. The
sutures201, 202 are coupled to the lengthwise end of the
needles198, 199 disposed within the recesses of the
needle retaining member192. The
needle retaining member192 is oriented with respect to the
segment portion189 and the
arm members180 such that the
needles198, 199 are oriented perpendicular to the
mesh205 to enable routing the
needles198, 199 through the edges of the hernia defect. As will be discussed in more detail below, the specific positions of the
needle retaining member192 and overall lengthwise configuration of the
arm members180 corresponds to the tension of the
tension members210 and the relative positioning of the proximal ends 122, 142 of the first and second
elongated member120, 140.
Reference is next made to
FIGS. 9A-9B, which illustrate perspective views of the proximal ends 122, 142 of the first and second
elongated member120, 140 corresponding to two different operational states of the
hernia repair system100.
FIG. 9Aillustrates an unlocked in which the proximal ends 122, 142 are rotationally aligned with one another. The unlocked configuration corresponds to the
distal end160 of the second
elongated member140 being rotationally aligned with the
distal end130 of the first
elongated member120 to enable distal articulation of the
arm members180, as illustrated in
FIGS. 3 and 4. In addition, the proximal ends 122, 142 are translationally disposed adjacent to one another in the unlocked or distal freedom configuration such that the distal-most region of the second
elongated member140
proximal end142 is adjacent to the proximal-most region of the first
elongated member120
proximal end122. As described above, the unlocked configuration corresponds to a particular rotational alignment of the distal ends 130, 160 to enable distal articulation of the
arm members180. The particular configuration of the proximal ends 122, 142 may also be referred to as a distal freedom configuration because the
arm members180 are enabled to lengthwise articulate freely between the radial extended and distal lengthwise extended configurations. Operationally, the
system100 is initially inserted through a trocar with the proximal ends 122, 142 in the unlocked configuration (
FIG. 9A) to enable a particular unlocked rotational alignment of the distal ends 160, 130 (
FIG. 10) and the
arm members180 to be positioned within a distal extended configuration (
FIG. 12) that is capable of being contained within the diameter of the internal channel of the trocar. As will be described further below in reference to
FIG. 10, the
tension members210 are sized and positioned so as to have little or no tension in the unlocked configuration of the proximal ends 122, 142. Therefore, the
tension members210 do not exert any substantial tension forces affecting the articulation position of the
arm members180 in the unlocked configuration.
illustrates the locked configuration in which the proximal ends 122, 142 are translationally separated and rotated with respect to one another. The second
elongated member140
proximal end142 is retracted or translated proximally away from the first
elongated member120
proximal end122, causing the
flat region146 to extend a particular distance through the proximal opening to the
internal channel126 such that the
notch148 is translationally aligned with the proximal opening. The
notch148 of the second
elongated member140 enables the second
elongated member140 to be rotated with respect to the first
elongated member120 within the flat shaped proximal opening of the first
elongated member120. The rotation of the
proximal end142 of the second
elongated member140 corresponds to a rotation of the
distal end160. The direction and degree of rotation between the proximal ends 142, 122 may be determined by the shape of the
notch148. The
notch148 may be specifically shaped to limit the rotation of the second
elongated member140 to ensure accurate rotational positioning of the
distal end160 of the second
elongated member140 with respect to the
distal end130 of the first
elongated member120. The illustrated extended and rotational position of the proximal ends 142, 122 corresponds to both tensioning the
tension members210 and rotating the
distal end160 of the second
elongated member140 with respect to the first
elongated member120. Operationally, the proximal ends 122, 142 are subsequently manipulated by a user into the locked configuration (
FIG. 9B) to enable a particular locked rotational alignment of the distal ends 160, 130 (
FIG. 11) that locks the
arm members180 into a radial extended configuration (
FIG. 13). The radial extended configuration of the
system100 is capable of attaching and suturing the mesh over the herniated region. Since the
tension members210 are rigidly coupled to both the first and second
elongated members120, 140, the relative extension or translation causes a tension force in the
tension members210 which will be described further below with reference to
FIGS. 11 and 13.
Reference is next made to
FIG. 10, which illustrates a detailed perspective view of the distal ends 130, 160 of the first and second
elongated members120, 140 in an unlocked configuration of the
hernia repair system100. The unlocked configuration of the distal ends 130, 160 corresponds to a rotational alignment of the
channels162 with the
arm articulation regions132. Likewise, the
stops164 are rotationally aligned with the
spacer regions134. Because of the adjacent positioning of the proximal ends 122, 142 (
FIG. 9A), the
tension members210 are not tensioned and therefore do not exert any substantial forces upon the
arm members180 in this configuration. The positioning of the distal ends 160, 130 enables the
proximal segments182 of the
arm members180 to articulate within an approximate ninety degree freedom between a perpendicular (shown) position and a substantially parallel lengthwise position. The
proximal segments182, articulate lengthwise within the
articulation regions132 and
channels162 of the distal ends 130, 160 respectively.
Reference is next made to
FIG. 11, which illustrates a detailed perspective view of the distal ends 130, 160 of the first and second
elongated members120, 140 in a locked configuration of the
hernia repair system100. The second
elongated member140
distal end160 is rotated with respect to the first
elongated member130
distal end130 such that the
stops164 are rotationally aligned with the
arm members180 and the
arm articulation regions132. The relative rotational positioning of the distal ends 130, 160 locks or substantially restricts the articulation freedom of the
proximal segment182 of the
arm members180 into the illustrated radial or perpendicular configuration with respect to the first
elongated member120. Because of the corresponding separation of the proximal ends 122, 142 (
FIG. 9B), the
tension members210 become taut and exert a radially-oriented tension force upon the
arm members180 and effectively restrict the medial and
distal segments184, 190 into the radially extended configuration
FIG. 13).
Reference is next made to
FIG. 12, which illustrates a detailed perspective view of the
arm members180,
mesh205, and the distal ends 160, 130 of the first and second
elongated members120, 140 in a distal lengthwise extended configuration of the
arm members180 of the
hernia repair system100. The lengthwise extended configuration of the
arm members180 corresponds to the unlocked configurations of the distal and proximal ends 130, 160, 122, 142 of the first and second
elongated members120, 140. The
arm members180 extend substantially lengthwise away from the distal ends 130, 160 in a distal direction. The
mesh205 is disposed between the
arm members180. The
arm members180 are substantially lengthwise aligned including lengthwise alignment of the proximal, medial, and
distal segments182, 184, 190. However, the unlocked configuration of the distal and proximal ends 130, 160, 122, 142 of the first and second
elongated members120, 140 corresponds to articulation freedom of the
arm members180, and therefore they are not locked into the lengthwise extended configuration. Likewise, the
tension members210 are not taut and do not exert any form of tension force upon the
arm members180 into the lengthwise extended configuration. The male-female pin type coupling described in detail with reference to
FIG. 6, between the
segments182, 184, 190 prevents the inward articulation of the
arm members180 beyond the lengthwise extended configuration. The
pin retaining members192 are illustrated in a radial oriented configuration but are capable of articulating such that the needles (not shown) are proximally oriented and lengthwise folded against the
corresponding arm members180. Therefore, as the
system100 is operationally initially inserted into a trocar, the needles (not shown) extending from the
needle retaining members192 will be forced to articulate proximally to enable lengthwise alignment and system containment within the trocar channel.
Reference is next made to
FIG. 13, which illustrates a detailed perspective view of the
arm members180,
mesh205, and the distal ends 130, 160 of the first and second
elongated members120, 140 in a radially extended configuration of the
arm members180 of the
hernia repair system100. The radially extended configuration of the
arm members180 corresponds to the locked configurations of the distal and proximal ends 130, 160, 122, 142 of the first and second
elongated members120, 140. The
arm members180 are radially extended substantially perpendicular to the first and second
elongated members120, 140. The corresponding locked configuration of the proximal ends 122, 142 causes the
tension members210 to be taut, thereby exerting a tension force across the
arm members180. Because of the routing configuration of the
tension members210, this causes the
arm members180 to be radially extended with respect to the distal ends 130, 160. The
mesh205 is positioned on the distal side of the
arm members180. The
tension members210 are directly coupled to the
needle retaining members192, and therefore the tension force also causes the
needle retaining members192 to orient the needles proximally substantially perpendicular to the
arm members180. In operation, the
arm members180 are extended into the radial extended configuration upon being disposed distal of the herniated region such that the
mesh205 may be appropriately positioned on the distal side of the entire herniated region. The orientation of the
needles201, 202 enables a user to then retract the entire system and cause the needles to pierce the fascial edges around the herniated region to enable external suturing of the
mesh205 over the herniated region.
Reference is next made to
FIG. 14, which illustrates a detailed perspective view of the
arm members180 and the distal ends 130, 160 of the first and second
elongated members120, 140 in a partially refracted configuration of the
hernia repair system100. The illustrated partially retracted configuration corresponds to the unlocked configurations of the distal and proximal ends 130, 160, 122, 142 of the first and second
elongated members120, 140. The
arm members180 are illustrated in a partially articulated configuration representing the process through which the
arm members180 are retracted from between the herniated region and the
mesh205. The articulation freedom of the arm members in the unlocked configurations enables the
individual segments182, 184, 190 of each arm member to articulate proximally lengthwise to correspond to the extraction position. Therefore, the
arm members180 may be retracted from a narrow region contained between the
mesh205 and the hernia.
In operation, systems in accordance with the present invention may be utilized to insert and attach a mesh over the distal side of a herniated region via the herniated opening itself. A trocar is positioned through the herniated opening so as to provide a proximal to distal channel extending externally to internally. Initially, the
system100 is in the unlocked configurations (
FIGS. 9A and 10) of the distal and proximal ends 130, 160, 122, 142 of the first and second
elongated members120, 140, including a substantially distal extended configuration of the arm members 180 (
FIG. 13). The
system100 is initially translationally distally inserted by a user through the internal channel of a trocar until the
arm members180 and
distal ends130, 160 are distal to the hernia. An optional telescoping sleeve may be utilized to contain the
arm members180 within the distal extended configuration (
FIG. 12) during insertion. The optional sleeve may then be automatically or manually telescopically retracted proximally from the
arm members180 and
distal ends130, 160 once the
arm members180 and
distal ends130, 160 are distally disposed with respect to the hernia. The user may then proximally retract and subsequently rotate the second
elongated member140
proximal end142 from the first
elongated member120
proximal end122 causing engagement of the locked configurations (
FIGS. 9B and 11) and substantial locking of the
arm members180 into the radial extended configuration (
FIG. 14). The user may then proximally translate the
entire system100 so as to extend the
needles198, 199 through the abdominal wall around the herniated region and position the
mesh205 over the distal side of the herniated region. The needles may then be externally interwoven to suture the
mesh205. Various needle release systems may be utilized to release the needles from the needle retaining members. The user may then oppositely rotate and subsequently distally translate the second
elongated member140
proximal end142 with respect to the first
elongated member120
proximal end122, disengaging the locked configurations into the unlocked configurations (
FIGS. 9A and 10) of the distal and proximal ends 130, 160, 122, 142 of the first and second
elongated members120, 140. The reverse rotation is oriented opposite to the rotation used to engage the locked configurations. The unlocked configurations enable the
segments182, 184, 190 of the
arm members180 to independently articulate within a lengthwise proximal orientation. The user then proximally retracts the
system100 from between the
mesh205 and the herniated region. As the
segments182, 184, 190 translate into the internal channel of the trocar, they are forced to individually articulate by varying degrees to enable the retraction. The
arm members180 are thereby proximally lengthwise articulated from the radial extended configuration back to the lengthwise distal extended configuration over the course of the retraction process.
Reference is next made to
FIG. 15, which illustrates a perspective view of an alternative hernia repair system, designated generally at 500. The illustrated system 500 incorporates multiple alternative configurations which may be used individually or in conjunction to form alternative embodiments. The system 500 includes a first and second elongated member similar to the
system100 illustrated in
FIGS. 1 and 2. The second
elongated member330 is slidably coupled within the first
elongated member320. The external first
elongated member320 further includes a
rotational guide indicator325, an
elongated member310, and a stopper 315. The illustrated first and
second members320, 330 include the proximal handles on the left and distal ends on the right. The illustrated system 500 further includes an optional snare system including a wire with loops 370, a spring-biased
clamp350, and a pull handle 360. The wire extends through an internal channel of the second
elongated member330 and the spring-biased
clamp350. The wire includes the loop 370 on the distal end and the pull handle region 360 on the proximal end. The system further includes an optional guide system of a
radial clamping member250, including an
internal clamping member280 and a
radial surface260, 270. The optional independent systems illustrated in
FIG. 15will be described below in further detail.
Reference is next made to
FIGS. 16-19, which illustrate acts related to the coupling of an independent mesh and suture to the alternative system illustrated in
FIG. 15. It will be appreciated that various mesh and suture configurations may be utilized to provide flexibility in mesh type and suture type used. One
specific mesh305 and
suture420 embodiment provides modular coupling schemes on the
distal segments390 of each of the
arm members380 to facilitate independent or
commercial suture420 and/or mesh 305 coupling. The use of commercially
available mesh305 and
sutures420 provides flexibility in system use and enables the user to specifically select optimal mesh and suture types for the particular patient. Rather than incorporating preloaded sutures and retracting
needles198,199,201,202 (FIGS. 6,8,13) as described in the embodiment above, the
distal segments390 of each
arm member380 may be configured to each include recesses through which alternative
independent sutures420 may be coupled. For example, the recesses may be sized to accept a Keith type needle. In addition, a
snare system350, 360, 370 (
FIG. 15) may be incorporated to route the
independent suture420 of a commercial needle-suture pack through the system 500. The
snare system350, 360, 370 may include a wire routed through the
arm members380 and through the second
elongated member330 to the proximal handle region as shown in
FIG. 15. The path of the wire extends from the distal end through an internal channel of the second
elongated member330 out the proximal handle region of the second
elongated member330. The wire of the
snare system350, 360, 370 includes a central loop or coupler 370 disposed on the distal end and a pull handle 360 disposed at the proximal end of the system 500 extending out from the handle. The pull handle portion 360 of the wire extends through a spring-biased
clamping member350 for retaining the proximal end of the wire and later the independent sutures external of the second
elongated member330.
To preload independent sutures and mesh with the above described alternative configuration, the following acts are performed. The system 500 is positioned in the radially extended configuration (
FIG. 16) to facilitate the preloading of the
independent sutures420 and
mesh305. The user extends the
needles410 of each commercial needle-suture pack through the recess at the
distal segment390 of each
arm member380, thereby coupling the sutures to the
distal segments390. The
independent mesh305 is positioned below the radially
extended arm members380 such that the edges of the mesh are substantially aligned with the
distal segments390 of each
arm member380. The user extends the
needles410 of the needle-suture packs through the corresponding portions of the
mesh305 and then through the distal central loop portion 370 of the wire of the snare as shown in
FIG. 17. The
needles410 are cut and removed from the
sutures420. The proximal handle portion 360 of the
snare system350, 360, 370 is then proximally retracted to route the sutures through the system 500 and circumferentially couple the
mesh305 at the
distal segment390 of each
arm member380 for standard operation as shown in
FIG. 18. The
snare system350, 360, 370 is fully retracted to cause the
sutures420 to extend through the spring-biased
clamping member350, thereby loading the independent sutures and mesh 305 on the system 500 as shown in
FIG. 19. The
snare system350, 360, 370 may be removed, and the system 500 may be reconfigured into the extended configuration (
FIG. 20). The optional systems and methods described below to confine the
arm members380 and mesh 305 may also be used prior to performing the procedure, including but not limited to confining the
arm members380 and mesh within a sleeve member or manually confining the
mesh305 and
arm members380 as shown in
FIG. 21. The system 500 is then inserted and the
mesh305 is deployed in accordance with the procedure described above. Rather than extending the
integrated needles201, 202 (
FIG. 13) as described above, the user may use the alternative guiding system in combination with standard laparoscopic suture passers to affix the
mesh305 with a second set of independent sutures (not shown). Once the
mesh305 is affixed to the proximal side of the hernia opening, the spring-biased
clamping member305 is removed and the first set of mesh coupling sutures 420 are allowed to translate back through the system 500. Since the
sutures420 will remain coupled to recesses of the
distal segments390, they are able to be subsequently removed from the patient when the entire system 500 is retracted. A second mesh and suture embodiment may include a pre-loaded mesh but facilitate a similar system for enabling a user to couple independent or commercially available sutures.
Reference is next made to
FIG. 20, which illustrates an optional guiding system disposed over the arm members and mesh, designated generally at 250. It will be appreciated that various external members may be used to externally guide and/or secure the system 500 and/or trocar with respect to the patient during operation. In addition, the optional systems may provide an accurate guide to the external locations at which the suturing will occur. One embodiment includes incorporating an externally disposed
radial clamping member250 with the system described above, so as to provide a visual guide (i.e. jig) for the user and/or to facilitate stabilizing the system 500 during operation. The
radial clamping member250 includes an
internal opening280 and a
radial surface270, 260. In operation, the
radial clamping member250 is externally coupled over an external portion of the outermost member for the particular procedure. For example, if the
repair system100/500 is inserted through an incision, the radial clamping member is coupled over an external portion of the elongated medial portion of the first
elongated member310/120. Alternatively, if the
system100/500 is inserted through a
trocar200, the radial clamping member is coupled over an external portion of the elongated medial portion of the
trocar200. The internal opening of the radial clamping member is shaped to correspond to the external diameter of either the first
elongated member310/120 or the
trocar200. The diameter of the internal opening may be slightly larger, thereby facilitating a slidable radial external coupling. The slidable coupling of the
radial clamping member250 enables a user to translate it against the external side of the patient during the procedure to provide both a guide and a stabilizing mechanism. The
radial clamping member250 and radially extended
arm members380 may effectively sandwich against the proximal and distal sides of the hernia to provide stability during the mesh coupling procedure. The internal opening may also include a clamping system to secure the radial clamping member to a particular region of the first
elongated member310/120 or
trocar200 throughout the procedure. Various clamping systems may be utilized, including but not limited to levers, compliant springs, etc. The
radial surface260, 270 extends radially from the internal opening. The illustrated
radial surface260, 270 includes a plurality of
radial distance indicators270 to illustrate alternative mesh diameter distances. The illustrated
radial surface260, 270 also includes a
quadrant member270 to indicate four radial distance positions. The internal opening is disposed substantially within the center of the radial surface. In operation, the
radial surface260, 270 is substantially orthogonal to the lengthwise orientation of the system 500/100 and the trocar 200 (
FIGS. 16, 18, and 19). Therefore, the
radial surface260, 270 is also configured to be substantially parallel to the
mesh305 and
arm members380 in the radial extended configuration (
FIG. 20). The
radial surface260, 270 includes a substantial two dimensional area corresponding to the
mesh305 and
arm members380 in the radial extended configuration (
FIG. 20). In addition, the
radial surface260, 270 may include a plurality of suture indicators to provide a reliable external guide as to the location of the internal sutures.
illustrate optional confinement systems for confining the arm members and mesh in accordance with embodiments of the present invention. The described optional confinement systems may be used in conjunction with the embodiment described in reference to
FIGS. 1-14, the alternative embodiment illustrated in
FIG. 15, or any combination thereof. It will be appreciated that the optional confinement systems for the arm members and mesh may be utilized prior to insertion of the
system100 within a
trocar200 or other incision. A first arm member and mesh confinement procedure embodiment may include using a sleeve member (not shown) to radially compress and confine the
mesh305 and
arm members380 in the unlocked extended configuration (
FIGS. 15 and 22), thereby loading the system. The sleeve member may be a cylindrically shaped hollow region comprising an elastic material having a diameter wider than the
elongated portion310 of the first
elongated member320. In operation, a
mesh305 may be coupled to the
arm members180 as described above. Subsequently, the sleeve member may be translated over the
arm members180, thereby retaining the
arm members180 and mesh within the internal region of the sleeve member in an elongated configuration. Prior to use, the second
elongated member330 may be proximally translated away from the first
elongated member320 by a particular distance, causing the distal end of the second
elongated member320 including the
arm members380 and mesh 305 to be partially retracted internally within the first
elongated member320. The relative diameter of the sleeve member with respect to the first
elongated member320 will cause the sleeve member to separate from the
arm members180 and
mesh205 and independently translate externally over the first
elongated member320. The partial external translation of the sleeve member over the first
elongated member320 will thereby engage the sleeve member with the first
elongated member320 while substantially confining the
arm members380 and mesh 305 within a particular radial elongated region. The particular amount of translation of the sleeve member over the first
elongated member320 could be biased or stopped by an O-ring or other semi-compressible region of the sleeve member. Likewise, similar O-ring and semi-compressible regions could be used to induce a particular amount of resistance as the sleeve member is partially translated externally over the first elongated member. Various other tactile feedback systems may also be incorporated to provide the user with guidance toward optimal translation.
A second arm member and mesh confinement procedure embodiment may eliminate the sleeve member. In operation, the
mesh305 is coupled to the
arm members380 via one of the procedures described above. The
mesh305 and
arm members380 are then manually confined within a radial configuration (
FIG. 21) and inserted directly into a trocar or incision. These alternative embodiments facilitate the efficient insertion of the
arm members380 and mesh 305 within a standard diameter trocar or other incision. The containment or radial confinement of the
arm members380 and mesh 305 enable the use of thicker mesh materials which may otherwise obstruct or impede the insertion of the system within a standard trocar. The remaining components of the system may be the same as that described above. Likewise, the remaining acts of the hernia repair procedure may also be the same as that described above.
Various other embodiments have been contemplated, including combinations in whole or in part of the embodiments described above. Various additional components and or materials may be used in conjunction with embodiments of the present invention.
Claims (20)
1. A hernia repair system comprising:
a first elongated member having a distal end, a proximal end, and an internal channel extending therebetween, wherein the distal end includes a distal opening to the internal channel and the proximal end includes a proximal opening to the internal channel;
a second elongated member extending through the internal channel of the first elongated member, wherein the second elongated member includes a locking member disposed on a distal end;
a plurality of arm members moveably coupled to the distal end of the first elongated member, wherein the arm members each comprise a plurality of moveably intercoupled segments, wherein the moveable coupling of the arm members to the first elongated member is restricted to limit the articulation of the arm members between a lengthwise extended distal configuration and a radial extended configuration, and wherein the arm members further include a distal segment disposed on a lengthwise end of each arm member opposite the moveable coupling with the first elongated member;
a plurality of tension members rigidly coupled to and extending between the distal segment of each of the plurality of arm members and the second elongated member, wherein the tension of the plurality of tension members corresponds to the configuration of the plurality of arm members, and wherein the plurality of tension members extend substantially adjacent to the plurality of segments and through the internal channel of the first elongated member; and
wherein the radial extended configuration includes a proximal translational displacement of the second elongated member with respect to the first elongated member, a tension in the plurality of tension members, and a radial extended position of the plurality of arm members substantially perpendicular to the first elongated member.
2. The system of
claim 1, wherein the distal side of the plurality of arm members are configured to releasably couple to a mesh in the radial extended configuration.
3. The system of
claim 1, further includes a snare system comprising a wire extending through an internal channel of the second elongated member.
4. The system of
claim 3, wherein the wire includes a loop disposed on the distal end and a pull handle disposed on the proximal end.
5. The system of
claim 1, wherein the pull handle extends through a spring-biased clamp external of the second elongated member.
6. The system of
claim 1, further includes a guiding system comprising a radial clamping member.
7. The system of
claim 6, wherein the radial clamping member is configured to radially couple to an external surface of the first elongated member.
8. The system of
claim 6, wherein the radial clamping member includes a radial surface corresponding to a radial length of the arm members in the radial extended configuration.
9. The system of
claim 6, wherein the radial clamping member is configured to translate along the first elongated member.
10. The system of
claim 1, further including a sleeve member configured to radially confine a mesh coupled to the distal side of the arm members.
11. The system of
claim 10, wherein the sleeve member is a cylindrical hollow member having a cross sectional diameter larger than the diameter of the distal opening to the internal channel of the first elongated member.
12. The system of
claim 11, wherein the sleeve member comprises an elastic material.
13. A hernia repair system comprising:
a first elongated member having a distal end, a proximal end, and an internal channel extending therebetween, wherein the distal end includes a distal opening to the internal channel and the proximal end includes a proximal opening to the internal channel;
a second elongated member extending through the internal channel of the first elongated member, wherein the second elongated member includes a locking member disposed on a distal end;
a plurality of arm members moveably coupled to the distal end of the first elongated member, wherein the arm members each comprise a plurality of moveably intercoupled segments, wherein the moveable coupling of the arm members to the first elongated member is restricted to limit the articulation of the arm members between a lengthwise extended distal configuration and a radial extended configuration, and wherein the arm members further include a distal segment disposed on a lengthwise end of each arm member opposite the moveable coupling with the first elongated member;
a plurality of tension members rigidly coupled to and extending between the distal segment of each of the plurality of arm members and the second elongated member, wherein the tension of the plurality of tension members corresponds to the configuration of the plurality of arm members, and wherein the plurality of tension members extend substantially adjacent to the plurality of segments and through the internal channel of the first elongated member;
wherein the radial extended configuration includes a proximal translational displacement of the second elongated member with respect to the first elongated member, a tension in the plurality of tension members, and a radial extended position of the plurality of arm members substantially perpendicular to the first elongated member; and
a snare system comprising a wire extending through an internal channel of the second elongated member.
14. A method for distally coupling a mesh and set of sutures to a hernia repair system, comprising the acts of:
providing a hernia repair system comprising:
a first elongated member having a distal end, a proximal end, and an internal channel extending therebetween, wherein the distal end includes a distal opening to the internal channel and the proximal end includes a proximal opening to the internal channel;
a second elongated member extending through the internal channel of the first elongated member, wherein the second elongated member includes a locking member disposed on a distal end;
a plurality of arm members moveably coupled to the distal end of the first elongated member, wherein the arm members each comprise a plurality of moveably intercoupled segments, and wherein the arm members further include a distal segment disposed on a lengthwise end of each arm member opposite the moveable coupling with the first elongated member;
a plurality of tension members rigidly coupled to and extending between the distal segment of each arm member and the second elongated member;
a snare system comprising a wire extending through an internal channel of the second elongated member;
coupling a plurality of sutures independently to the lengthwise end of each arm member;
coupling the plurality of sutures to a mesh;
coupling the plurality of sutures to the snare system;
retracting the snare system through the second elongated member; and
coupling the mesh to the arm members.
15. The method of
claim 14, wherein the acts of coupling include routing a needle through the lengthwise end of each arm member, mesh, and snare system, respectively.
16. The method of
claim 15, wherein the needle and sutures are part of a needle-suture pack.
17. The method of
claim 14, wherein the act of retracting the snare system through the second elongated member includes retracting the sutures through a spring-biased coupler.
18. The method of
claim 14, further including the act of manually confining the coupled mesh and arm members in an extended configuration.
19. The method of
claim 14, further including the act of inserting the coupled mesh and arm members within a sleeve member in an extended configuration, wherein the sleeve member is a cylindrically shaped hollow member having a cross section diameter larger than the distal opening to the internal channel of the first elongated member.
20. The method of
claim 19, wherein the act of inserting the coupled mesh and arm members within a sleeve member further includes proximally translating the second elongated member from the first elongated member a particular amount causing the sleeve member to translate over an external surface of the first elongated member a particular amount.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US14/140,652 US9011414B2 (en) | 2009-04-04 | 2013-12-26 | Systems and methods for hernia repair |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US12/418,579 US8641699B2 (en) | 2009-04-04 | 2009-04-04 | Systems and methods for hernia repair |
US14/140,652 US9011414B2 (en) | 2009-04-04 | 2013-12-26 | Systems and methods for hernia repair |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US12/418,579 Continuation-In-Part US8641699B2 (en) | 2009-04-04 | 2009-04-04 | Systems and methods for hernia repair |
Publications (2)
Publication Number | Publication Date |
---|---|
US20140107675A1 US20140107675A1 (en) | 2014-04-17 |
US9011414B2 true US9011414B2 (en) | 2015-04-21 |
Family
ID=50476046
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US14/140,652 Expired - Fee Related US9011414B2 (en) | 2009-04-04 | 2013-12-26 | Systems and methods for hernia repair |
Country Status (1)
Country | Link |
---|---|
US (1) | US9011414B2 (en) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2017021964A1 (en) * | 2015-08-02 | 2017-02-09 | Morena Medical Ltd. | Hernia repair device, system and method |
US20180079274A1 (en) * | 2016-09-22 | 2018-03-22 | Beijingwest Industries Co., Ltd. | Air suspension assembly |
Families Citing this family (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9339365B2 (en) | 2011-07-07 | 2016-05-17 | David D. Park | Device and method for delivering grafts |
WO2017075608A1 (en) * | 2015-10-30 | 2017-05-04 | New York Society For The Relief Of The Ruptured And Crippled, Maintaining The Hospital For Special Surgery | Suture sleeve patch and methods of delivery within an existing arphroscopic workflow |
US11090145B2 (en) | 2017-07-06 | 2021-08-17 | Park Surgical Innovations, Llc | Device for delivering grafts at a surgical site and method |
EP3648677A4 (en) * | 2017-07-06 | 2021-01-27 | Park Surgical Innovations, Llc | SURGICAL SITE-LEVEL GRAFTS PLACEMENT DEVICE AND ASSOCIATED PROCESS |
US11771416B2 (en) * | 2020-07-14 | 2023-10-03 | Arthrex, Inc. | Surgical tools and associated graft augmentation techniques |
Citations (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5147374A (en) | 1991-12-05 | 1992-09-15 | Alfredo Fernandez | Prosthetic mesh patch for hernia repair |
US5304187A (en) | 1992-06-30 | 1994-04-19 | United States Surgical Corporation | Surgical element deployment apparatus |
USD347061S (en) | 1992-04-17 | 1994-05-17 | Phillips Edward H | Laparoscopic tool for inserting a mesh prosthesis |
US5366460A (en) | 1990-10-11 | 1994-11-22 | Cook Incorporated | Apparatus and method for laparoscope hernia repair |
US5397332A (en) | 1993-09-02 | 1995-03-14 | Ethicon, Inc. | Surgical mesh applicator |
US5405360A (en) | 1992-02-24 | 1995-04-11 | United States Surgical Corporation | Resilient arm mesh deployer |
US5464403A (en) | 1992-10-29 | 1995-11-07 | General Surgical Innovations, Inc. | Placement tool and method for laparoscopic hernia repair |
US5540704A (en) * | 1992-09-04 | 1996-07-30 | Laurus Medical Corporation | Endoscopic suture system |
US5618290A (en) | 1993-10-19 | 1997-04-08 | W.L. Gore & Associates, Inc. | Endoscopic suture passer and method |
US5865802A (en) | 1988-07-22 | 1999-02-02 | Yoon; Inbae | Expandable multifunctional instruments for creating spaces at obstructed sites endoscopically |
US6409739B1 (en) * | 1997-05-19 | 2002-06-25 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to side anastomosis |
US6575988B2 (en) | 2001-05-15 | 2003-06-10 | Ethicon, Inc. | Deployment apparatus for supple surgical materials |
US20070112361A1 (en) | 2005-11-07 | 2007-05-17 | Schonholz Steven M | Surgical repair systems and methods of using the same |
US20070260179A1 (en) | 2004-10-14 | 2007-11-08 | Mordehai Sholev | Hernia Repair Device |
US20080188874A1 (en) | 2005-09-09 | 2008-08-07 | University Of South Florida | Laparoscopic hernia mesh spreader |
US8641699B2 (en) * | 2009-04-04 | 2014-02-04 | Adam J. Hansen | Systems and methods for hernia repair |
-
2013
- 2013-12-26 US US14/140,652 patent/US9011414B2/en not_active Expired - Fee Related
Patent Citations (16)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5865802A (en) | 1988-07-22 | 1999-02-02 | Yoon; Inbae | Expandable multifunctional instruments for creating spaces at obstructed sites endoscopically |
US5366460A (en) | 1990-10-11 | 1994-11-22 | Cook Incorporated | Apparatus and method for laparoscope hernia repair |
US5147374A (en) | 1991-12-05 | 1992-09-15 | Alfredo Fernandez | Prosthetic mesh patch for hernia repair |
US5405360A (en) | 1992-02-24 | 1995-04-11 | United States Surgical Corporation | Resilient arm mesh deployer |
USD347061S (en) | 1992-04-17 | 1994-05-17 | Phillips Edward H | Laparoscopic tool for inserting a mesh prosthesis |
US5304187A (en) | 1992-06-30 | 1994-04-19 | United States Surgical Corporation | Surgical element deployment apparatus |
US5540704A (en) * | 1992-09-04 | 1996-07-30 | Laurus Medical Corporation | Endoscopic suture system |
US5464403A (en) | 1992-10-29 | 1995-11-07 | General Surgical Innovations, Inc. | Placement tool and method for laparoscopic hernia repair |
US5397332A (en) | 1993-09-02 | 1995-03-14 | Ethicon, Inc. | Surgical mesh applicator |
US5618290A (en) | 1993-10-19 | 1997-04-08 | W.L. Gore & Associates, Inc. | Endoscopic suture passer and method |
US6409739B1 (en) * | 1997-05-19 | 2002-06-25 | Cardio Medical Solutions, Inc. | Device and method for assisting end-to side anastomosis |
US6575988B2 (en) | 2001-05-15 | 2003-06-10 | Ethicon, Inc. | Deployment apparatus for supple surgical materials |
US20070260179A1 (en) | 2004-10-14 | 2007-11-08 | Mordehai Sholev | Hernia Repair Device |
US20080188874A1 (en) | 2005-09-09 | 2008-08-07 | University Of South Florida | Laparoscopic hernia mesh spreader |
US20070112361A1 (en) | 2005-11-07 | 2007-05-17 | Schonholz Steven M | Surgical repair systems and methods of using the same |
US8641699B2 (en) * | 2009-04-04 | 2014-02-04 | Adam J. Hansen | Systems and methods for hernia repair |
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2017021964A1 (en) * | 2015-08-02 | 2017-02-09 | Morena Medical Ltd. | Hernia repair device, system and method |
CN108135585A (en) * | 2015-08-02 | 2018-06-08 | 莫尔研究应用有限公司 | Hernia mending device, system and method |
US20180079274A1 (en) * | 2016-09-22 | 2018-03-22 | Beijingwest Industries Co., Ltd. | Air suspension assembly |
Also Published As
Publication number | Publication date |
---|---|
US20140107675A1 (en) | 2014-04-17 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US8641699B2 (en) | 2014-02-04 | Systems and methods for hernia repair |
US9011414B2 (en) | 2015-04-21 | Systems and methods for hernia repair |
US20210275203A1 (en) | 2021-09-09 | Systems for performing endoscopic procedures |
US11109875B2 (en) | 2021-09-07 | Minimally invasive surgical assembly and methods |
US9326784B2 (en) | 2016-05-03 | Minimally invasive surgical assembly and methods |
US9033873B2 (en) | 2015-05-19 | Surgical retractor including rotatable knobs |
US9486238B2 (en) | 2016-11-08 | Minimally invasive surgical clamps, assemblies and methods |
US8133255B2 (en) | 2012-03-13 | Minimally invasive surgical assembly and methods |
US20170238915A1 (en) | 2017-08-24 | Devices, systems, and methods for wound closure |
CN110809445B (en) | 2023-05-16 | Needle guide instrument with lateral suture capture feature |
US20230043500A1 (en) | 2023-02-09 | Surgical access device including anchor with ratchet mechanism |
EP2289439A2 (en) | 2011-03-02 | Surgical portal apparatus including gear and lookout assembly |
US12114891B2 (en) | 2024-10-15 | Surgical access device with fixation mechanism and illumination mechanism |
US20240238009A1 (en) | 2024-07-18 | Surgical access device including an anchor having a suture retention mechanism |
US20240138876A1 (en) | 2024-05-02 | Surgical access device with fixation mechanism |
CN110831529A (en) | 2020-02-21 | Suture grasping instrument |
US11839405B2 (en) | 2023-12-12 | Surgical access device with fixation mechanism |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
2015-04-01 | STCF | Information on status: patent grant |
Free format text: PATENTED CASE |
2018-12-10 | FEPP | Fee payment procedure |
Free format text: MAINTENANCE FEE REMINDER MAILED (ORIGINAL EVENT CODE: REM.); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY |
2019-05-27 | LAPS | Lapse for failure to pay maintenance fees |
Free format text: PATENT EXPIRED FOR FAILURE TO PAY MAINTENANCE FEES (ORIGINAL EVENT CODE: EXP.); ENTITY STATUS OF PATENT OWNER: SMALL ENTITY |
2019-05-27 | STCH | Information on status: patent discontinuation |
Free format text: PATENT EXPIRED DUE TO NONPAYMENT OF MAINTENANCE FEES UNDER 37 CFR 1.362 |
2019-06-11 | FP | Lapsed due to failure to pay maintenance fee |
Effective date: 20190421 |